Safety and Efficacy of One Hour Weekly Taxol Infusion and Estramustine in Hormone Refractory Prostate Cancer
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.
Primary Purpose: Treatment
Abraham Chachoua, MD
New York University School of Medicine
United States: Federal Government
|Kaplan Cancer Center||New York, New York 10016|
|Mount Sinai Medical Center, NY||New York, New York 10029|