Docetaxel and Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases That Progressed on the Docetaxel and Placebo Group of MDA-ID-030008
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.
Drug: Imatinib mesylate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008|
- Treatment efficacy [ Time Frame: 12 weeks after initiation of crossover therapy ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: From registration to disease progression, up to 32 months ] [ Designated as safety issue: No ]Time of progression was defined as the time of appearance of symptoms attributable to disease progression, the first demonstrated clinical sign or radiological evidence of disease progression, or the time of first of consecutive prostate-specific antigen (PSA) increments that achieved 25% increase over baseline or nadir (or death during the study), whichever was earliest.
- Response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Experimental: Docetaxel + Imatinib Mesylate
Docetaxel intravenous (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.
30 mg/m^2 IV on days 1, 8, 15, and 22 every 42 daysDrug: Imatinib mesylate
600 mg orally daily
- 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 of therapy.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 9 months.
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Paul Mathew||M.D. Anderson Cancer Center|
|Study Chair:||Christopher Logothetis, MD||M.D. Anderson Cancer Center|