Official Title: Randomized Double-Blind Placebo-Controlled Phase II Study Of Intravenous CCI-779 Administered Weekly To Patients With Androgen-Independent Prostate Cancer
Status: COMPLETED
Status Verified Date: 2002-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Randomized phase II trial to determine the effectiveness of CCI-779 in treating patients who have progressive prostate cancer
Detailed Description: 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 finalcross-over visit Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 150 patients will be accrued for this study