Kidney Cancer Clinical Trial
Official title:
Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide
may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if
interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with
or without thalidomide in treating patients who have previously untreated metastatic or
unresectable kidney cancer.
OBJECTIVES:
- 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
arms.
- Arm I: Patients receive interferon alfa-2b subcutaneously (SC) twice daily beginning on
day 1.
- 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
CR.
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
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