Home
Search
Study Topics
Glossary
|
Study 3 of 884 for search of: | United States, Delaware |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) National Cancer Institute of Canada Eastern Cooperative Oncology Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00072046 |
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 |
Drug: bevacizumab Drug: recombinant interferon alfa |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma |
Study Start Date: | October 2003 |
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.
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
Study Chair: | Brian I. Rini, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study Chair: | Simon Tanguay, MD | McGill Cancer Centre at McGill University |
Study Chair: | Janice P. Dutcher, MD | Our Lady of Mercy Medical Center Comprehensive Cancer Center |
Study ID Numbers: | CDR0000335292, CALGB-90206, CAN-NCIC-REC1, ECOG-CALGB-90206 |
Study First Received: | November 4, 2003 |
Last Updated: | October 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00072046 |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer |
Interferon-alpha Interferon Type I, Recombinant Interferons Urogenital Neoplasms Bevacizumab Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Interferon Alfa-2a Adenocarcinoma Clear cell renal cell carcinoma Interferon Alfa-2b Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |