AzTrials
AzTrials

Ovarian Granulosa Cell TumorPhase 2NCT01042522

Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

A Phase 2 study testing Bleomycin Sulfate, Carboplatin and Cisplatin in people with Ovarian Granulosa Cell Tumor and Ovarian Gynandroblastoma, run by GOG Foundation at 219 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bleomycin Sulfate, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
219 sitesUnited States
Study dates
8 Feb 2010to 2 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]
  • Patients must have newly diagnosed, stage IIA - IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy
  • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
  • Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control
  • Patients in the measureable disease cohort must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Show all 19Show fewer
  • Platelet greater than or equal to 100,000/mcl
  • Creatinine no greater than the institutional upper limits of normal
  • Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3.0 x ULN (CTCAE grade 1)
  • Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)
  • Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
  • No signs of clinically significant hearing loss
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must have pulmonary function sufficient to receive bleomycin, with normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted
  • Patients with a history of hypersensitivity reactions to prior chemotherapy administered for previous cancer diagnoses are eligible to participate in the study, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted

Who cannot join

  • Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs)
  • Patients with apparent stage I disease who have not undergone a staging procedure
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years
  • Woman who are pregnant or breastfeeding
  • 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 can consult the study chair or study co-chairs for uncertainty in this regard

Trial locations and contacts

219 sites in 1 country.

219 sites in 1 country

United States219 sites

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Southwest Gynecologic Oncology Associates Inc

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • 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

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • 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

  • Big Horn Basin Cancer Center

    Cody, Wyoming, 82414

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Coffeyville Regional Medical Center

    Coffeyville, Kansas, 67337

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • 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

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • Northside Hospital-Forsyth

    Cumming, Georgia, 30041

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Central Ohio Breast and Endocrine Surgery

    Gahanna, Ohio, 43230

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Benefis Healthcare- 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

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • HaysMed University of Kansas Health System

    Hays, Kansas, 67601

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Truman Medical Centers

    Kansas City, Missouri, 64108

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster Radiation Oncology

    Lancaster, Ohio, 43130

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Central Georgia Gynecologic Oncology

    Macon, Georgia, 31201

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Olathe Health Cancer Center

    Olathe, Kansas, 66061

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Radiation Oncology of Northern Illinois

    Ottawa, Illinois, 61350

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Ascension Via Christi - Pittsburg

    Pittsburg, Kansas, 66762

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • Geisinger Medical Oncology-Selinsgrove

    Selinsgrove, Pennsylvania, 17870

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Memorial Sloan Kettering Sleepy Hollow

    Sleepy Hollow, New York, 10591

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62702

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri, 63127

  • Southwest Illinois Health Services LLP

    Swansea, Illinois, 62226

  • Olive View-University of California Los Angeles Medical Center

    Sylmar, California, 91342

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Wexford Health and Wellness Pavilion

    Wexford, Pennsylvania, 15090

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary

This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed advanced or recurrent chemonaive ovarian sex cord-stromal tumors.

SECONDARY OBJECTIVES:

  1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.

II. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.

III. To evaluate response rate in the subset of patients with measurable disease.

TERTIARY OBJECTIVES:

  1. To collect fixed and/or frozen tumor tissue for future translational research studies.

II. To explore the utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors and to examine changes in these markers with treatment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bleomycin sulfate IV on day 1 and etoposide phosphate* IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have received prior radiotherapy receive etoposide phosphate on days 1-4.

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

Being tested
Bleomycin Sulfate, Carboplatin, Cisplatin, Etoposide Phosphate, Laboratory Biomarker Analysis
Medical subject headings
Granulosa cell tumor of the ovary, Ovarian gynandroblastoma, Sertoli-Leydig Cell Tumor

What participants receive

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

  • Bleomycin SulfateBiological

    Also called Blanoxan, BleMomycine, Blenoxane, Bleo-cell

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Etoposide PhosphateDrug

    Also called Etopophos

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

Study groups in NCT01042522
Study groupRoleWhat they receive
Arm I (paclitaxel, carboplatin)ExperimentalPatients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel
Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)ExperimentalPatients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bleomycin Sulfate; Drug: Cisplatin; Drug: Etoposide Phosphate; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Progression-free Survival (PFS)

    The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

    Measured: From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.

Secondary outcomes (2)

  1. Tumor Response Rate

    Proportion of evaluable patients with complete or partial tumor response by RECIST 1.1 criteria.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (ORR = CR + PR).

    Measured: Median followup time was 48 months.

  2. Overall Survival (OS)

    The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported.

    Measured: From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.

Timeline

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

  1. First posted5 Jan 2010 (estimated)
  2. Study start8 Feb 2010
  3. Primary completion12 Jun 2020
  4. Study completion2 Nov 2022 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01042522
Sponsor's protocol ID
GOG-0264
Other IDs
NCI-2011-02000, CDR0000662814, GOG-0264, GOG-0264, U10CA180868, U10CA027469
Status last verified
Dec 2021
First submitted
1 Jan 2010
Last updated
25 Jan 2022

Publications

  • Brown J, Miller A, Holman LL, Backes F, Nagel C, Bender D, Miller DS, Powell MA, Westin SN, Bonebrake A, Muller CY, Secord AA, Crane E, Schorge J, Tew WP, Sood AK, Bookman MA, Aghajanian C, Gershenson DM. Results of a randomized phase II trial of paclitaxel and carboplatin versus bleomycin, etoposide and cisplatin for newly diagnosed and recurrent Chemonaive stromal ovarian tumors: An NRG oncology/gynecologic oncology group study14. Gynecol Oncol. 2024 Nov;190:283-290. doi: 10.1016/j.ygyno.2024.09.002. Epub 2024 Sep 12.

    PubMed 39265466

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bleomycin Sulfate, Carboplatin and Cisplatin in people with Ovarian Granulosa Cell Tumor and Ovarian Gynandroblastoma, run by GOG Foundation at 219 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 219 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01042522, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.

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