Estramustine and Paclitaxel in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining estramustine and paclitaxel in treating patients who have prostate cancer that has not responded to hormone therapy.
Drug: estramustine phosphate sodium
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Safety and Efficacy of One Hour Weekly Taxol Infusion and Estramustine in Hormone Refractory Prostate Cancer|
|Study Start Date:||April 1997|
|Primary Completion Date:||August 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of paclitaxel with estramustine in patients with hormone refractory prostate cancer. II. Evaluate the toxicity of this combination at the MTD of paclitaxel in this patient population. III. Determine any objective tumor response arising from this treatment in these patients.
OUTLINE: This is a dose escalation study of paclitaxel. Patients receive oral estramustine daily on days 1-3 and paclitaxel IV over 1 hour on day 3 weekly for 6 weeks followed by 1 week of rest. Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of paclitaxel 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 toxicities.
PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005048
|United States, New York|
|Kaplan Cancer Center|
|New York, New York, United States, 10016|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|Study Chair:||Abraham Chachoua, MD||New York University School of Medicine|