Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases
- Compare time to progression in patients with androgen-independent prostate cancer and
bone metastases treated with docetaxel with vs without imatinib mesylate.
- Compare the response rates in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to hemoglobin (< 11g/dL vs ≥ 11 g/dL), alkaline phosphatase (normal vs
elevated), number of prior regimens (0 vs 1 or 2), and ECOG performance score (0 or 1 vs 2).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV on days 1, 8, 15, and 22 and oral imatinib
mesylate once daily on days 1-43.
- Arm II: Patients receive docetaxel as in arm I and oral placebo once daily on days
In both arms, courses repeat every 43 days in the absence of disease progression or
unacceptable toxicity. Patients who progress on arm II may cross over to arm I.
PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Time to progression
Baseline to 3 years, or until disease progression
M.D. Anderson Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|