AzTrials
AzTrials

Kidney CancerPhase 3NCT00072046

Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)

A Phase 3 study testing bevacizumab and recombinant interferon alfa in people with Kidney Cancer, run by Alliance for Clinical Trials in Oncology at 493 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Kidney Cancer
What is being tested?
bevacizumab and recombinant interferon alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
732 participants
Where
493 sitesin 2 countries
Study dates
Oct 2003to Nov 2012
Phase
Phase 3
Are there results?
None posted in the registry

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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell carcinoma (RCC)
  • Conventional clear cell carcinoma
  • Metastatic or unresectable disease
  • The following characteristics and cellular types are excluded:
  • True papillary
  • Sarcomatoid features without a clear cell component
  • Chromophobe
  • Oncocytoma
  • Collecting duct tumor
  • Transitional cell carcinoma
  • Measurable or nonmeasurable disease, including any of the following:
  • Unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., physical exam or chest x-ray) OR 10 mm by spiral CT scan or MRI
  • The following are considered nonmeasurable disease:
  • Small lesions
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Irradiated lesions, unless progression is documented after radiotherapy
  • RCC paraffin tissue blocks or unstained slides must be available
  • No evidence of prior or concurrent CNS metastases by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No history of clinically significant bleeding

Hepatic

  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN
  • No proteinuria > 1+
  • Proteinuria ≥ 2+ allowed provided protein is < 2 g/24-hour urine collection

Cardiovascular

  • No deep venous thrombosis within the past year
  • No cerebrovascular accident within the past year
  • No peripheral vascular disease with claudication on < 1 block
  • No uncontrolled hypertension defined as blood pressure ≥160 mm Hg (systolic) and/or ≥ 90 mm Hg (diastolic) while on medication
  • No New York Heart Association class II-IV congestive heart failure
  • No angina pectoris requiring nitrate therapy
  • No myocardial infarction within the past 6 months
  • No other significant cardiovascular disease

Pulmonary

  • No pulmonary embolus within the past year
  • No ongoing hemoptysis

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • No preexisting thyroid abnormality in which normal thyroid function cannot be maintained by medication
  • No delayed wound healing, ulcers, or bone fractures
  • No uncontrolled psychiatric disorder
  • No other currently active* malignancy except nonmelanoma skin cancer NOTE: *Disease is not considered currently active if patient completed anticancer therapy and is considered to have < 30% risk of relapse

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior systemic immunotherapy for RCC
  • No prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitors, or antiangiogenic treatment of any kind
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

  • No prior systemic chemotherapy for RCC
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent systemic corticosteroid therapy except the following:
  • Topical and inhaled steroids
  • Replacement therapy for adrenal insufficiency
  • No concurrent hormones except those administered for nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior palliative radiotherapy to metastatic lesions allowed provided at least 1 measurable or nonmeasurable lesion remains untreated
  • No concurrent palliative radiotherapy

Surgery

  • At least 4 weeks since prior major surgery and recovered

Other

  • No other prior systemic investigational therapy for RCC
  • No other prior adjuvant or neoadjuvant systemic therapy for RCC
  • No concurrent full-dose oral or parenteral anticoagulation* NOTE: *Low-dose (1 mg) warfarin for maintenance of catheter patency and/or daily prophylactic aspirin is allowed

Trial locations and contacts

493 sites in 2 countries.

304 sites in 2 countries

United States300 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Akron City Hospital at Summa Health System

    Akron, Ohio, 44304

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31703

  • Hematology-Oncology Associates, PC

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87106

  • Lovelace Medical Center at Lovelace Sandia Health System

    Albuquerque, New Mexico, 87108

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Emory University Hospital - Atlanta

    Altanta, Georgia, 30322

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48100

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Fox Valley Hematology and Oncology

    Appleton, Wisconsin, 54911-3496

  • Arlington Cancer Center - Arlington

    Arlington, Texas, 76012

  • Arroyo Grande Community Hospital

    Arroyo Grande, California, 93420

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Hematology and Oncology of Northeast Georgia

    Athens, Georgia, 30607

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Augusta Oncology Associates

    Augusta, Georgia, 30901

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201-1595

  • St. Agnes Cancer Center

    Baltimore, Maryland, 21229

  • CancerCare of Maine at Eastern Maine Medial Center

    Bangor, Maine, 04401

  • Baton Rouge General Regional Cancer Center

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Ochsner Clinic of Baton Rouge

    Baton Rouge, Louisiana, 708169990

  • Battle Creek Health System

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • MeritCare Clinic - Bemidji

    Bemidji, Minnesota, 56601

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Mecosta County General Hospital

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Health System

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, P.C.

    Bismarck, North Dakota, 58501

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • St. Elizabeth Boardman Cancer Center

    Boardman, Ohio, 44512

  • Lynn Regional Cancer Center of Boca Raton Community Hospital

    Boca Raton, Florida, 33486

  • Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Cancer Center at Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Brainerd Medical Center

    Brainerd, Minnesota, 56401

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cancer Institute of New Jersey at the Cooper University Hospital

    Camden, New Jersey, 08103

  • Graham Hospital

    Canton, Illinois, 61520

  • University Hospitals Ireland Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • St. Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25304

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017-3417

  • University of Illinois Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Adena Regional Medical Center

    Chillicothe, Ohio, 54601

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cancer Center of Colorado Springs

    Colorado Springs, Colorado, 80907

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • John B. Amos Community Cancer Center

    Columbus, Georgia, 31902

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Batte Cancer Center at Northeast Medical Center

    Concord, North Carolina, 28025

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Halifax Medical Center

    Daytona Beach, Florida, 32115

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224-2522

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Kent General Hospital at Bayhealth Medical Center

    Dover, Delaware, 19901

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Oncology Hematology Associates of Northern Pennsylvania, P.C. at Hahne Regional Cancer Center

    DuBois, Pennsylvania, 15801

  • Wendt Regional Cancer Center at Finley Hospital

    Dubuque, Iowa, 52001

  • Cancer Care Center at St. Luke's Hospital

    Duluth, Minnesota, 55802

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital

    Eden, North Carolina, 27288

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Alexian Brothers Cancer Care Center

    Elk Grove Village, Illinois, 60007

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Vince Lombardi Cancer Center - Elkhorn

    Elkhorn, Wisconsin, 53121

  • Union Hospital Cancer Center at Union Hospital

    Elkton MD, Maryland, 21921

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Evanston Northwestern Health Care - Evanston Hospital

    Evanston, Illinois, 60201

  • Dakota Cancer Institute at Innovis Health - Dakota Clinic

    Fargo, North Dakota, 58103

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Medical Group

    Fargo, North Dakota, 58122

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48532

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80524

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Fort Wayne Medical Oncology and Hematology, Incorporated

    Fort Wayne, Indiana, 46815

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Fremont Area Medical Center

    Fremont, Nebraska, 68025

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Mercy and Unity Cancer Center at Mercy and Unity Hospitals

    Fridley, Minnesota, 55432

  • Shands Cancer Center at the University of Florida - Jacksonville

    Gainesville, Florida, 32610

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Medical and Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • Comprehensive Cancer Center at Gaston Memorial

    Gastonia, North Carolina, 28053

  • Jones Clinic

    Germantown, Tennessee, 38138

  • Oncology Alliance, S.C. - Milwaukee - East

    Glendale, Wisconsin, 53212

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Spectrum Health Hospital - Blodgett Campus

    Grand Rapids, Michigan, 49506

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311-6519

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27401

  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

    Greenville, North Carolina, 27858

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Greenville Hospital System Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Virginia Oncology Associates - Hampton

    Hampton, Virginia, 23666

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17105

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Hematology & Oncology Clinic

    Hattiesburg, Mississippi, 34902

  • Hattiesburg Clinic, P.A.

    Hattiesburg, Mississippi, 39401

  • Mason District Hospital

    Havana, Illinois, 62644

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolula, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • St. Francis Medical Center

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • Marshall University Medical Center

    Huntington, West Virginia, 25701

  • St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Huntsville Hospital

    Huntsville, Alabama, 35801

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242

  • Foote Hospital

    Jackson, Michigan, 49201

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224-9980

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Freeman Cancer Institute at Freeman Health System

    Joplin, Missouri, 64804

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Provena St. Mary's Wasser Regional Cancer Center - Kankakee

    Kankakee, Illinois, 60901

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Cancer Center at the Good Samaritan Health Systems

    Kearney, Nebraska, 68847

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Kenton Oncology, Inc.

    Kenton, Ohio, 43326

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Rappahannock General Hospital

    Kilmarnock, Virginia, 22482

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Baptist Hospital Of East Tennessee

    Knoxville, Tennessee, 37920

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Oncology Institute of Greater Lafayette

    Lafayette, Indiana, 47904

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Watson Clinic

    Lakeland, Florida, 33805

  • Haematology-Oncology Associates of Ohio and Michigan, P.C.

    Lambertville, Michigan, 48144

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Comanche County Memorial Hospital

    Lawton, Oklahoma, 73505

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Central Pennsylvania Hematology and Medical Oncology Associates, PC

    Lemoyne, Pennsylvania, 17043

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Bryan LGH Medical Center West

    Lincoln, Nebraska, 68502

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • St. Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80502

  • Lynchburg Hematology-Oncology Clinic

    Lynchburg, Virginia, 24501

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • UW Health Oncology

    Madison, Wisconsin, 53715

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • Holy Family Memorial Medical Center

    Manitowoc, Wisconsin, 54221

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • St. John's Hospital

    Maplewood, Minnesota, 55109

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middlesex Hospital Cancer Center

    Middletown, Connecticut, 06457

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Medical Consultants

    Milwaukee, Wisconsin, 53215

  • Froedtert Hospital and Medical College of Wisconcin

    Milwaukee, Wisconsin, 53226-3596

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • Fairview University Medical Center - University Campus

    Minneapolis, Minnesota, 55455

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • Providence Holy Cross Cancer Center

    Mission Hills, California, 91346-9600

  • Alegent Health Community Memorial Hospital

    Missouri Valley, Iowa, 51555

  • Trinity Medical Center - East

    Moline, Illinois, 61265

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital System

    Monroe, Michigan, 48162

  • Cancer Center at the Mountainside Hospital

    Montclair, New Jersey, 07042

  • Chippewa County - Montevideo Hospital

    Montevideo, Minnesota, 56265

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Hematology Oncology Consultants Ltd.

    Naperville, Illinois, 60540

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8032

  • Cancer Center at Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70112

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

Other trials in United States

Canada4 sites

  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V8

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma

RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer).

PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab.

Secondary

  • Compare the time to disease progression and objective response rates in patients treated with these regimens.
  • Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no) and number of risk factors for disease progression (0 vs 1-2 vs 3 or more). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive interferon alfa-2b subcutaneously (SC) three times a week.
  • Arm II: Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then annually for up to 10 years after study entry.

PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.

Conditions
Kidney Cancer
Being tested
bevacizumab, recombinant interferon alfa
Keywords
stage IV renal cell cancer, clear cell renal cell carcinoma, recurrent renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

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

  • bevacizumabBiological

    10mg/kg IV infusion on Days 1 \& 15 of each cycle

  • recombinant interferon alfaBiological

    9 million units subQ injection 3 x/week for 4 weeks

Study groups in NCT00072046
Study groupRoleWhat they receive
InterferonExperimentalTreatment with interferon alfa 2b
Receives: Biological: recombinant interferon alfa
Interferon + bevacizumabExperimentalAddition of bevacizumab to interferon alfa 2b treatment
Receives: Biological: bevacizumab; Biological: recombinant interferon alfa

What is being measured

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

  1. Overall Survival

    Measured: 5 years

Secondary outcomes (2)

  1. Time to progression

    Measured: q 3 cycles

  2. Toxicity

    Measured: q cycle

Timeline

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

  1. First posted6 Nov 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionJan 2004
  4. Study completionNov 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072046
Sponsor's protocol ID
CALGB-90206
Other IDs
U10CA031946, CAN-NCIC-REC1, CDR0000335292
Status last verified
Jul 2016
First submitted
4 Nov 2003
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Archer L, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol. 2010 May 1;28(13):2137-43. doi: 10.1200/JCO.2009.26.5561. Epub 2010 Apr 5.

    PubMed 20368558

  • Rini BI, Halabi S, Rosenberg J, et al.: Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: results of overall survival for CALGB 90206. [Abstract] J Clin Oncol 27 (Suppl 15): A-LBA5019, 2009.

  • Rini BI, Halabi S, Rosenberg JE, et al.: CALGB 90206: a phase III trial of bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in metastatic renal cell carcinoma. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-350, 2008.

  • Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Ou SS, Archer L, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol. 2008 Nov 20;26(33):5422-8. doi: 10.1200/JCO.2008.16.9847. Epub 2008 Oct 20.

    PubMed 18936475

  • Rini BI, Halabi S, Taylor J, Small EJ, Schilsky RL; Cancer and Leukemia Group B. Cancer and Leukemia Group B 90206: A randomized phase III trial of interferon-alpha or interferon-alpha plus anti-vascular endothelial growth factor antibody (bevacizumab) in metastatic renal cell carcinoma. Clin Cancer Res. 2004 Apr 15;10(8):2584-6. doi: 10.1158/1078-0432.ccr-03-0605.

    PubMed 15102658

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

  • Nixon AB, Halabi S, Liu Y, Starr MD, Brady JC, Shterev I, Luo B, Hurwitz HI, Febbo PG, Rini BI, Beltran H, Small EJ, Morris MJ, George DJ. Predictive Biomarkers of Overall Survival in Patients with Metastatic Renal Cell Carcinoma Treated with IFNalpha +/- Bevacizumab: Results from CALGB 90206 (Alliance). Clin Cancer Res. 2022 Jul 1;28(13):2771-2778. doi: 10.1158/1078-0432.CCR-21-2386.

    PubMed 34965953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab and recombinant interferon alfa in people with Kidney Cancer, run by Alliance for Clinical Trials in Oncology at 493 sites in 2 countries.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 493 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (time frame: 5 years). 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 NCT00072046, which also lists 7 linked publications.

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 6 Jul 2016.

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