AE-941 in Treating Patients With Metastatic Kidney Cancer
RATIONALE: AE-941 may stop the growth of kidney cancer by stopping blood flow to the tumor.
PURPOSE: Randomized phase III trial to determine the effectiveness of AE-941 in treating patients who have metastatic kidney cancer that has not responded to biological therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||AE-941 (NEOVASTAT) Versus Placebo in Metastatic Renal Cell Carcinoma Patients Who Are Refractory to Immunotherapy|
|Study Start Date:||October 2000|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Compare survival of patients with metastatic renal cell carcinoma refractory to immunotherapy treated with AE-941 (Neovastat) versus placebo. II. Compare the time to progression and one-year survival rate of patients treated with this regimen. III. Determine the safety of this regimen in these patients. IV. Compare the overall tumor response rate, duration of response, and quality of life of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to number of organs with metastases (1 vs more than 1) and ECOG performance status (0 vs 1). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral AE-941 (Neovastat) twice a day. Arm II: Patients receive oral placebo twice a day. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed on day 1 and then every 8 weeks thereafter. Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study within 12 months.