AzTrials
AzTrials

Fallopian Tube Endometrioid AdenocarcinomaPhase 3NCT01167712

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

A Phase 3 study testing Bevacizumab, Carboplatin and Computed Tomography in people with Fallopian Tube Endometrioid Adenocarcinoma and Fallopian Tube Mucinous Adenocarcinoma, run by National Cancer Institute (NCI) at 564 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab, Carboplatin and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
692 participants
Where
564 sitesin 3 countries
Study dates
27 Sep 2010to 2 Jul 2026
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary Surgery and Neoadjuvant Chemotherapy with Interval Cytoreductive Surgery Patients:
  • Patients must have measurable disease; at least one target lesion must have a minimum length of 1 cm in both the long and short axis (determined at the local site); for primary surgery patients, if no radiographic evidence of measurable disease is obtained prior to registration this can be based on surgical findings; imaging then would need to be completed in the 14 days between Gynecology Oncology Group (GOG) registration and chemotherapy initiation
  • After GOG registration, the American College of Radiology [ACR] Imaging Core Laboratory will confirm target lesion as required per protocol; the GOG-eligibility (RECIST) scan and baseline T0 perfusion CT scans will be reviewed prior to the intermediate T1 perfusion CT time point
  • Primary Surgery Patients:
  • Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the completion of initial abdominal surgery, appropriate imaging studies and with appropriate tissue available for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual
  • Neoadjuvant Chemotherapy (NAC) with Interval Cytoreductive Surgery (ICS) Patients:
Show all 25Show fewer
  • For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required; the tissue must be consistent with a Müllerian origin; patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
  • Patients with the following histologic epithelial cell types are eligible: serous, endometrioid, clear cell, mucinous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube; of note, patients with clear cell and mucinous tumors will be eligible unless there is a higher priority protocol
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine =< 1.5 x institutional upper limit normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Patients must have a GOG performance status of 0, 1, or 2
  • Patients must be entered within 12 weeks of diagnostic/staging surgery
  • Patients who have met the pre-entry requirements
  • An approved informed consent and authorization permitting release of personal health information and must be signed by the patient or guardian
  • Only applies for patients who elect to receive bevacizumab:
  • Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not high-dose progestins for management of anorexia while on protocol-directed therapy or prior to disease progression due to thrombophlebitis risk
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a partial prothrombin time (PTT) < 1.2 times the upper limit of normal; (heparin, lovenox or alternative anticoagulants are acceptable)
  • All patients enrolled into GOG-0262 at sites where ACRIN 6695 is open will be enrolled in the advanced imaging protocol; patients receiving adjuvant or neoadjuvant chemotherapy are eligible for ACRIN 6695; the following sentence does not apply to those patients entered after 02/08/2012: if a patient declines to participate in the perfusion imaging portion of the protocol, a clinical rationale for declination of imaging form will be completed as part of the data submission for ACRIN 6695
  • ACRIN 6695 Eligible Patients:
  • Confirmation of ACRIN 6695 eligibility after the baseline T0 perfusion computed tomography (CT) will be assessed by the ACR Imaging Core Lab: At least one target lesion must have a minimum length of 1 cm in both the long and short axis (as determined by the local site), at least half of the target lesion must have attenuation greater than or equal to 10 Hounsfield Units (HU) on the unenhanced CT, and at least half of the lesion must have maximum enhancement greater than or equal to 5 HU in the perfusion CT scan (as determined by the ACR Imaging Core Lab)

Who cannot join

  • Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage I-A or I-B low grade epithelial ovarian or fallopian tube cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
  • With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy
Show all 32Show fewer
  • Patients with acute hepatitis or active infection that requires parenteral antibiotics
  • Patients with clinically significant cardiovascular disease; this includes:
  • Myocardial infarction or unstable angina < 6 months prior to registration
  • New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
  • Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
  • Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
  • Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the Statistical and Data Center (SDC) randomization desk for uncertainty in this regard
  • Patients with known allergy to cremophor or polysorbate 80
  • Only applies to patients who elect to receive bevacizumab:
  • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
  • Patients with CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
  • Patients with a history of CVA within six months
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24-hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
  • Patients with or with anticipation of invasive procedures as defined below:
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy (cycle 2)
  • Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression such as colostomy or enterostomy reversal, secondary cytoreductive surgery, or second look surgery; please consult with the SDC Randomization Desk prior to patient entry for any questions related to the classification of surgical procedures
  • Any tissue biopsy, such as a core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle 2)
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
  • Patients with metastasis tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patients at high risk of lethal hemorrhage during treatment with bevacizumab (ie. hemoptysis, liver rupture)
  • ACRIN 6695 Ineligible Patients:
  • Patients with contraindication to iodinated contrast for perfusion CT imaging
  • Patients who receive Metformin within 48 hours before perfusion CT imaging

Trial locations and contacts

564 sites in 3 countries.

305 sites in 3 countries

United States300 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Women's Cancer Care Associates LLC

    Albany, New York, 12208

  • Southwest Gynecologic Oncology Associates Inc

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Northern Virginia Pelvic Surgery Associates

    Annandale, Virginia, 22003

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • PeaceHealth Medical Group PC

    Bellingham, Washington, 98226

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Hartford HealthCare - Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Island Gynecologic Oncology

    Brightwaters, New York, 11718

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • John Muir Medical Center-Concord

    Concord, California, 94520

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45459

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Saint Elizabeth Healthcare Edgewood

    Edgewood, Kentucky, 41017

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Rocky Mountain Gynecologic Oncology PC

    Englewood, Colorado, 80110

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • GenesisCare USA - FGO

    Fort Myers, Florida, 33905

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Hematology Oncology Associates of Fredericksburg Inc

    Fredericksburg, Virginia, 22408

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates-Hampton

    Hampton, Virginia, 23666

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Illinois CancerCare-Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Allegiance Health

    Jackson, Michigan, 49201

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Southeast Gynecologic Oncology Associates

    Jacksonville, Florida, 32204

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Freeman Health System

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Kaiser Permanente-Rock Creek

    Lafayette, Colorado, 80026

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • The Watson Clinic

    Lakeland, Florida, 33805

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Memorial Medical Center-Las Cruces

    Las Cruces, New Mexico, 88011

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Long Beach Memorial Medical Center-Todd Cancer Institute

    Long Beach, California, 90806

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • Norton Hospital Pavilion and Medical Campus

    Louisville, Kentucky, 40202

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Centra Alan B Pearson Regional Cancer Center

    Lynchburg, Virginia, 24501

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Central Georgia Gynecologic Oncology

    Macon, Georgia, 31201

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Holy Family Hospital

    Methuen, Massachusetts, 01844

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Garnet Health Medical Center

    Middletown, New York, 10940

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

Other trials in United States

South Korea4 sites

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Seoul National University Hospital

    Seoul, 110-744

  • Yongdong Severence Hospital

    Seoul, 135-720

Other trials in South Korea

Canada1 site

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: GOG-0262: A Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865) in the Treatment of Primary Stage II, III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging to Evaluate Treatment Response in Patients Participating in GOG-0262

This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that tumors need to grow. It is not yet known whether giving paclitaxel with combination chemotherapy once every three weeks is more effective than giving paclitaxel once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if the weekly paclitaxel regimen increases the time until first progression or death (progression-free survival [PFS]) compared to the every-3-week paclitaxel regimen in women with primary stage II, III or IV epithelial ovarian, peritoneal or fallopian tube cancer who are receiving carboplatin with or without bevacizumab.

SECONDARY OBJECTIVES:

  1. To determine if the weekly paclitaxel increases the duration of overall survival compared to the every-3-week paclitaxel when combined with carboplatin with or without bevacizumab.

II. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to the incidence of severe or serious adverse events when it is combined with carboplatin with or without bevacizumab.

III. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to patients' self-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)-Trial Outcome Index (TOI), when paclitaxel is combined with carboplatin with or without bevacizumab. (As of 02/08/2012, the QOL portion of this study is complete; patients enrolled after this date will not have QOL assessments)

TRANSLATIONAL RESEARCH OBJECTIVES:

  1. To evaluate single nucleotide polymorphisms (SNPs) associated with progression-free survival and toxicity in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer using genome wide association studies (GWAS).* II. To evaluate genomic signatures in tumor tissues which are predictive for patient survival in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer.* III. To evaluate the association between serum and plasma biomarkers and response to anti-angiogenesis therapy in advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer.*

NOTE: *As of 02/08/2012, the translational research (TR) portion of this study is complete; patients enrolled after this date will not have TR specimens collected.

IMAGING PRIMARY OBJECTIVES:

  1. To determine whether larger changes in the tumor perfusion parameters from baseline timepoint (T0) to early-therapy T2 are prognostic of higher progression-free survival (PFS) rate at 6 months (PFS-6) from enrollment in patients treated with weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.***

IMAGING SECONDARY OBJECTIVES:

  1. To determine whether larger changes in tumor perfusion parameters from baseline T0 to intermediate T1 and from T1 to T2 are prognostic of higher PFS-6 in patients treated with weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.* II. To determine whether larger changes in tumor perfusion parameters values from T0 to T1, T0 to T2, and T1 to T2 are prognostic of better overall survival in all treatment arms.* III. To assess the association between changes in tumor perfusion parameters before and after chemotherapy initiation (T0 to T1) and subsequent best tumor response according to standard anatomic Response Evaluation Criteria in Solid Tumors (RECIST).* IV. To assess the association between tumor perfusion parameters before chemotherapy and subsequent best tumor response according to RECIST, PFS-6, and overall survival.* V. To test the assumption that tumor perfusion parameters are reliable, user-independent, and reproducible parameters of tumor microvascular characteristics; a subgroup of 15 patients will have repeat computed tomography (CT) perfusion studies at the intermediate T1 time point.***

NOTE: ***Patients enrolled after February 8, 2012 must participate in the ACRIN 6695 component at ACRIN-qualified institutions.

OUTLINE: Patients are randomized to 1 of 2 treatment arms (beginning on 04-30-2012, the trial is no longer randomized and the chemotherapy regimen is selected and declared prior to enrolling in the study).

ARM I (adjuvant chemotherapy suboptimally debulked): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

ARM II (neoadjuvant chemotherapy with interval cytoreductive surgery): Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.

Patients in both arms may receive optional** bevacizumab IV over 30-90 minutes on day 1 beginning in course 2. Courses of bevacizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients in Arm II receive bevacizumab during courses 2, 5, and 6 only.

NOTE: **Before enrolling onto this study, each patient chooses whether the study treatment will include concurrent and maintenance bevacizumab.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Being tested
Bevacizumab, Carboplatin, Computed Tomography, Paclitaxel, Therapeutic Conventional Surgery
Medical subject headings
Brenner Tumor, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called ABP 215, ABP-215, ABP215, Alymsys

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgery

Study groups in NCT01167712
Study groupRoleWhat they receive
Arm I (adjuvant chemotherapy suboptimally debulked)ExperimentalPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.
Receives: Biological: Bevacizumab; Drug: Carboplatin; Procedure: Computed Tomography; Drug: Paclitaxel; Procedure: Therapeutic Conventional Surgery
Arm II (neoadjuvant chemotherapy)ExperimentalPatients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.
Receives: Biological: Bevacizumab; Drug: Carboplatin; Procedure: Computed Tomography; Drug: Paclitaxel; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival

    First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. Progression is defined using response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: The timeframe is from enrollment onto the study up to 3 years following enrollment.

Secondary outcomes (2)

  1. Median Duration of First Quartile Survival

    First Quartile Overall Survival

    Measured: The timeframe is from enrollment onto the study up to 3 years after enrollment

  2. Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)

    Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)

    Measured: 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2010 (estimated)
  2. Study start27 Sep 2010
  3. Primary completion1 Dec 2015
  4. Study completion2 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
692 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01167712
Sponsor's protocol ID
NCI-2011-03812
Other IDs
NCI-2011-03812, GOG-0262/ACRIN 6695, 11-00374, CDR0000681448, ACRIN 6695, GOG-0262, GOG-0262, U10CA180868
Status last verified
Dec 2025
First submitted
21 Jul 2010
Last updated
29 May 2026
Data monitoring committee
No

Publications

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

  • Chan JK, Brady MF, Penson RT, Huang H, Birrer MJ, Walker JL, DiSilvestro PA, Rubin SC, Martin LP, Davidson SA, Huh WK, O'Malley DM, Boente MP, Michael H, Monk BJ. Weekly vs. Every-3-Week Paclitaxel and Carboplatin for Ovarian Cancer. N Engl J Med. 2016 Feb 25;374(8):738-48. doi: 10.1056/NEJMoa1505067.

    PubMed 26933849

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in