Combination Chemotherapy in Treating Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of vinorelbine, paclitaxel, and estramustine in treating patients who have advanced cancer that has not responded to previous treatment.
|Leukemia Lymphoma Sarcoma Unspecified Adult Solid Tumor, Protocol Specific||Drug: estramustine phosphate sodium Drug: paclitaxel Drug: vinorelbine ditartrate||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I/II Study of Paclitaxel, Estramustine Phosphate, and Vinorelbine (PaclEVin)|
|Study Start Date:||September 1998|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004105
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Franco M. Muggia, MD||New York University School of Medicine|