Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
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/II trial to study the effectiveness of combination chemotherapy consisting of estramustine, paclitaxel, and carboplatin in treating patients with advanced prostate cancer.
Drug: endocrine-modulating drug therapy
Drug: estramustine phosphate sodium
Drug: goserelin acetate
Drug: leuprolide acetate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study of Weekly Intravenous Estramustine Phosphate in Combination With Paclitaxel and Carboplatin in Patients With Advanced Prostate Cancer|
|Study Start Date:||April 1998|
|Study Completion Date:||April 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine a safe weekly dose of intravenous estramustine (EM) in combination with paclitaxel (TAX) and carboplatin (CBDCA) in patients with advanced prostate cancer. II. Determine the safety and efficacy of this combination in androgen dependent vs androgen independent disease in these patients. III. Evaluate the pharmacokinetics of weekly intravenous EM and TAX in combination with CBDCA in these patients.
OUTLINE: Phase I is a dose escalation study of estramustine. Phase II is a two stage design study, in which patients are stratified according to androgen dependence (androgen dependent disease vs androgen independent disease). In phase I, patients receive estramustine IV over 1 hour via permanent venous access device on day 1 of weeks 1, 2, 3, and 4, followed by paclitaxel (TAX) IV over 1 hour. Carboplatin IV is administered over 30 minutes at the completion of TAX at week 1. Courses repeat every 4 weeks until disease progression or excessive toxicity or for up to 24 weeks. Patients with locally advanced androgen dependent prostate cancer may be considered for radical prostatectomy or radiotherapy after 4 courses. Androgen dependent patients not already on primary hormone therapy with a GnRH analog receive goserelin or leuprolide injections under the skin every 3 months while on the study, beginning during the first or second week of therapy. Three patients are entered at each dose level and must complete one course of therapy. If no patient experiences dose limiting toxicity (DLT), then 3 patients are treated at the next higher dose level. If 1 patient experiences DLT, then 3 more patients are treated at that same dose level. If 2 of 6 patients experience DLT, then that dose is declared the maximum tolerated dose (MTD). In phase II, a two stage design is applied to each patient population. Fourteen patients are enrolled in the first stage. If no responses are observed, the trial is stopped. If at least 1 response is observed, 11 additional patients will be enrolled onto the study.
PROJECTED ACCRUAL: A total of 6-18 patients will be accrued to phase I; phase II will accrue up to 50 patients within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003394
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||William K. Kelly, DO||Memorial Sloan Kettering Cancer Center|