Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
- Compare the overall and progression-free survival at 24 weeks in patients with
previously untreated metastatic or unresectable renal cell carcinoma treated with
interferon alfa-2b with or without thalidomide.
- Compare the safety of these 2 regimens in these patients.
- Compare the quality of life of patients treated with these 2 regimens.
- Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements
of angiogenesis such as serum and plasma angiogenic factor levels in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
nephrectomy (yes vs no), disease-free interval (no more than 1 year vs more than 1 year),
and ECOG performance status (0 vs 1 or 2). Patients are randomized to one of two treatment
- Arm I: Patients receive interferon alfa-2b subcutaneously (SC) twice daily beginning on
- Arm II: Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily
beginning on day 1.
Treatment in both arms continues in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response (CR) continue treatment for 24 weeks past
Quality of life is assessed prior to randomization and then every 4 weeks through week 24.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 346 patients (173 per arm) will be accrued for this study
within 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Michael S. Gordon, MD
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
United States: Federal Government
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|MBCCOP - University of New Mexico HSC||Albuquerque, New Mexico 87131|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|Iowa Lutheran Hospital||Des Moines, Iowa 50316-2301|
|John Stoddard Cancer Center at Iowa Methodist Medical Center||Des Moines, Iowa 50309|
|Mercy Cancer Center at Mercy Medical Center-Des Moines||Des Moines, Iowa 50314|
|Midlands Cancer Center at Midlands Community Hospital||Papillion, Nebraska 68128-4157|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|
|Comprehensive Cancer Center at Our Lady of Mercy Medical Center||Bronx, New York 10466|