Prostate Cancer Clinical Trial
Official title:
Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work
in different ways to stop tumor cells from dividing so they stop growing or die. Giving more
than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and
estramustine together works in treating patients with metastatic hormone therapy-refractory
prostate cancer.
OBJECTIVES:
Primary
- 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
regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
Secondary
- 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
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