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Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008
RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel with imatinib mesylate works in treating patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008.
OBJECTIVES: Primary * 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. Secondary * 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 of therapy. Patients are followed for 30 days. PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 9 months.
Age
All ages
Sex
MALE
Healthy Volunteers
No
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Start Date
May 1, 2003
Primary Completion Date
July 1, 2006
Completion Date
June 1, 2008
Last Updated
October 26, 2012
23
ACTUAL participants
Docetaxel
DRUG
Imatinib mesylate
DRUG
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT04550494
NCT05691465
Data Source & Attribution
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