Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
- Determine the objective response rate in patients with metastatic hormone-refractory
prostate cancer treated with paclitaxel, topotecan, and estramustine.
- Determine the progression-free and overall survival of patients treated with this
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the frequency and number of circulating tumor cells in patients before and
after treatment with this regimen and at disease progression.
- Determine the microtubule morphology, β-tubulin isotype pattern, apoptotic markers, and
metaphase chromosome alignment in circulating tumor cells in patients before and after
treatment with this regimen and at disease progression.
OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15; topotecan IV over
30 minutes on days 2, 9, and 16; and oral estramustine twice daily on days 1 and 2 of course
1 and on days 0-2, 7-9, and 14-16 of all subsequent courses. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Gary R. Hudes, MD
Fox Chase Cancer Center
United States: Federal Government