Docetaxel, Prednisone, and Vatalanib in Treating Patients With Advanced Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving vatalanib together with docetaxel and prednisone may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vatalanib when given together with docetaxel and prednisone and to see how well they work in treating patients with advanced prostate cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Docetaxel/Prednisone and PTK 787/ZK 222584 in Previously Untreated Metastatic Hormone Refractory Prostate Cancer|
- Time to prostate-specific antigen (PSA) and objective progression [ Designated as safety issue: No ]
- Response rate (PSA and objective) [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||February 2005|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
- Determine the dose-limiting toxicities and maximum tolerated dose of vatalanib when used in combination with docetaxel and prednisone in patients with chemotherapy-naive, metastatic, hormone-refractory prostate cancer. (phase I)
- Determine alterations in pharmacokinetics of docetaxel and vatalanib in these patients. (phase I)
- Determine the clinical efficacy of this regimen as measured by declines in prostate-specific antigen, measurable disease response, time to progression, and overall survival. (phase II)
OUTLINE: This is a phase I open-label, dose-escalation study of vatalanib* followed by a phase II study.
- Phase I: Patients receive docetaxel IV over 1 hour on day 2. Patients also receive oral prednisone twice daily and oral vatalanib once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Cohorts of 3-6 patients receive escalating doses of vatalanib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
NOTE: *Vatalanib is administered on days 5-21 during the first course only.
- Phase II: Patients receive prednisone, docetaxel, and vatalanib at the MTD as in phase I. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 93 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293371
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Eric J. Small, MD||University of California, San Francisco|