A Randomized Phase II Trial of Taxol/VP-16/Estramustine vs. Ketoconazole/Doxorubicin/Vinblastine/Estramustine in Androgen Independent Prostate Cancer
OBJECTIVES: I. Determine the clinical benefit of two combination chemotherapy regimens,
paclitaxel, etoposide, and estramustine vs ketoconazole, doxorubicin, vinblastine, and
estramustine in patients with androgen independent prostate cancer, as measured by prostate
specific antigen (PSA)-based response rate, time to progression, and overall survival. II.
Identify the most promising regimen to use in a phase III trial based on toxic effects,
PSA-based response rates, and clinical benefit.
OUTLINE: This is a randomized multicenter study. Patients are stratified according to risk
group: low volume disease (no more than 2 lesions on bone scan), intermediate volume (more
than 2 bone lesions confined to axial skeleton), or high volume (bone lesions in
appendicular skeletal or visceral lesions). Patients are randomized to one of two treatment
arms. Arm I: Patients receive oral estramustine three times a day and oral etoposide twice
daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days.
Arm II: Patients receive doxorubicin IV on days 1, 15, and 29, vinblastine IV on days 8, 22,
and 36, oral ketoconazole three times a day on days 1-7, 15-21, and 29-35, and oral
estramustine three times a day on days 8-14, 22-28, and 36-42. This regimen consists of 6
weeks of alternating chemotherapy and 2 weeks rest, for an 8 week course. Treatment
continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate specific antigen (PSA)- based Response Rate
8 week cycle
Randall E. Millikan, MD, PhD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|