A Phase I/II Study of Paclitaxel, Estramustine Phosphate, and Vinorelbine (PaclEVin)
OBJECTIVES: I. Establish the maximum tolerated doses (MTDs) and recommended Phase II doses
(RPTDs) of vinorelbine and paclitaxel when combined with a fixed dose of estramustine in
patients with advanced cancers or metastatic prostate cancer. II. Determine the toxicity
pattern of this regimen at the MTDs and at the RPTDs in these patients. III. Make
preliminary observations of antitumor activity in these patients treated with this regimen
as leads for the Phase II portion of this study. IV. Establish the efficacy of the RPTDs of
vinorelbine and paclitaxel when combined with estramustine in patients with prostate cancer
who fulfill the criteria for the Phase II portion of this study.
OUTLINE: This is a dose escalation, multicenter study of vinorelbine and paclitaxel.
Patients receive oral estramustine every 8 hours on days 0-2 and 7-9 and vinorelbine IV over
6-10 minutes immediately followed by paclitaxel IV over 1 hour on days 2 and 9. Courses
repeat every 21 days. Patients with complete response, partial response, or stable disease
continue treatment indefinitely in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of vinorelbine and paclitaxel
until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the
lowest dose at which 2 or more of 3-6 patients experience dose limiting toxicity. The
recommended Phase II dose of vinorelbine or paclitaxel is defined as the dose immediately
preceding the MTD.
PROJECTED ACCRUAL: A minimum of 12-16 patients will be accrued over 1 year for Phase I of
the study and a total of 14-25 patients will be accrued for Phase II of the study.
Primary Purpose: Treatment
Franco M. Muggia, MD
New York University School of Medicine
United States: Federal Government
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|