Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008
- Provide treatment with docetaxel and imatinib mesylate for patients with
androgen-independent prostate cancer and bone metastases that progressed while
receiving docetaxel and placebo on MDA-ID-030008.
- Determine the response rate and time to progression in these patients after crossover
from docetaxel and placebo to docetaxel and imatinib mesylate.
- Compare the modulation of the platelet-derived growth factor receptor pathway by
docetaxel and imatinib mesylate vs docetaxel and placebo in the same patient.
- Determine the quality of life of patients treated with this crossover regimen.
OUTLINE: This is an open-label, crossover, multicenter, extension study. Patients who
progressed on the placebo and docetaxel arm of MDA-ID-030008 crossover to receive docetaxel
and imatinib mesylate.
Patients receive docetaxel IV over 1 hour on days 1, 8, 15, and 22 and oral imatinib
mesylate once daily on days 1-42. Courses repeat every 42 days in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each therapy course, and at the completion
Patients are followed for 30 days.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 9 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
12 weeks after initiation of crossover therapy
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|