Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases
OBJECTIVES:
Primary
- Compare time to progression in patients with androgen-independent prostate cancer and
bone metastases treated with docetaxel with vs without imatinib mesylate.
Secondary
- 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
1-43.
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
study.
Interventional
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
No
Paul Mathew
Study Chair
M.D. Anderson Cancer Center
United States: Institutional Review Board
CDR0000354505
NCT00080678
May 2003
March 2008
Name | Location |
---|---|
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 |