Vinorelbine in Treating Patients With Metastatic Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine|
|Study Start Date:||October 1997|
|Study Completion Date:||September 1999|
|Primary Completion Date:||September 1999 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these patients. III. Evaluate the quality of life of these patients, and correlate quality of life with PSA response.
OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course. Patients with stabilization of their disease, partial response, or complete response, receive a maximum of 12 courses of treatment. Patients showing disease progression or severe toxic side effects discontinue treatment. Quality of life and pain are assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment. Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003259
|Aarau, Switzerland, 5001|
|Office of Walter Weber-Stadelman|
|Basel, Switzerland, CH 4051|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Istituto Oncologico della Svizzera Italiana|
|Lugano, Switzerland, CH-6900|
|Kantonsspital - Saint Gallen|
|Saint Gallen, Switzerland, CH-9007|
|Solothurn, Switzerland, 4500|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Zurich, Switzerland, CH-8008|
|Study Chair:||Rudolf Morant, MD||Cantonal Hospital of St. Gallen|