Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
M.D. Anderson Cancer Center
With
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.
Age
Any age
Sex
MALE
Healthy volunteers
Not accepted
