Finding studies
Finding studies
Take this into the appointment.
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Lead
University of California, San Francisco
With
OBJECTIVES: Primary * 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) Secondary * 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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
