Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (Al-PCa)
- Determine the maximum tolerated dose of paclitaxel and thalidomide administered with
estramustine in patients with progressive metastatic androgen-independent prostate
- Determine the efficacy of this regimen in these patients.
- Determine the objective response rate and prostate-specific antigen response rate in
patients treated with this regimen.
- Determine time to disease progression, performance status, analgesic consumption, and
survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a phase I dose-escalation study of paclitaxel and thalidomide followed by a
phase II study.
- Phase I: Patients receive oral estramustine three times daily on days 1-5 and 8-12,
oral thalidomide once daily on days 1-21, and paclitaxel IV over 3 hours on days 3 and
10. Courses repeat every 21 days in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of paclitaxel and thalidomide until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive paclitaxel, estramustine, and thalidomide as in arm I at the
PROJECTED ACCRUAL: A total of 48-75 patients (18 for phase I and 30-57 for phase II) will be
accrued for this study within 8-15 months.
Primary Purpose: Treatment
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|