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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) NCIC Clinical Trials Group Eastern Cooperative Oncology Group |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00072046 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: bevacizumab Biological: recombinant interferon alfa |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma |
| Enrollment: | 732 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | July 2015 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Interferon
Treatment with interferon alfa 2b
|
Biological: recombinant interferon alfa
9 million units subQ injection 3 x/week for 4 weeks
|
|
Experimental: Interferon + bevacizumab
Addition of bevacizumab to interferon alfa 2b treatment
|
Biological: bevacizumab
10mg/kg IV infusion on Days 1 & 15 of each cycle
Biological: recombinant interferon alfa
9 million units subQ injection 3 x/week for 4 weeks
|
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma (RCC)
The following characteristics and cellular types are excluded:
Measurable or nonmeasurable disease, including any of the following:
The following are considered nonmeasurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
No proteinuria > 1+
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent systemic corticosteroid therapy except the following:
Radiotherapy
Surgery
Other
Contacts and Locations
Show 493 Study Locations| Study Chair: | Brian I. Rini, MD | University of California, San Francisco |
More Information
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00072046 History of Changes |
| Other Study ID Numbers: | CDR0000335292, U10CA031946, CALGB-90206, CAN-NCIC-REC1, ECOG-CALGB-90206 |
| Study First Received: | November 4, 2003 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer |
|
Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a |
Interferon Alfa-2b Interferons Bevacizumab Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |