Randomized, Double-Blind, Placebo-Controlled, Phase II Study Of Intravenous CCI-779 Administered Weekly To Patients With Androgen-Independent Prostate Cancer
OBJECTIVES: I. Determine the safety of CCI-779 in patients with androgen-independent
prostate cancer. II. Determine the effects of CCI-779 on prostate-specific antigen levels in
these patients. III. Assess the pharmacokinetic parameters of CCI-779 in these patients. IV.
Assess the possible pharmacodynamic relationship of CCI-779 with clinical response in these
patients. V. Determine the impact of CCI-779 on the quality of life in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are randomized to 1 of 4 arms. Arm I: Patients receive low-dose CCI-779 IV over 30 minutes
weekly. Arm II: Patients receive high-dose CCI-779 IV over 30 minutes weekly. Arm III:
Patients receive low-dose placebo IV over 30 minutes weekly. Arm IV: Patients receive
high-dose placebo IV over 30 minutes weekly. Treatment continues in the absence of disease
progression or unacceptable toxicity. Patients who develop progressive disease while
receiving placebo may cross over to the equivalent dose of CCI-779. Quality of life is
assessed at baseline; at weeks 4, 8, 12, 24, and 36; and at final/cross-over visit. Patients
are followed every 3 months.
PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.
Primary Purpose: Treatment
Diane Prager, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|