Combination Chemotherapy Plus Peripheral Stem Cell Transplantation 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. Combining more than one drug with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation followed by combination chemotherapy in treating patients with metastatic prostate cancer that has not responded to hormone therapy.
|Prostate Cancer||Biological: filgrastim Drug: carmustine Drug: cisplatin Drug: melphalan Drug: vinorelbine tartrate Procedure: peripheral blood stem cell transplantation||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||High Dose Chemotherapy With Stem Cell Rescue Followed By Consolidation Treatment in Patients With Metastatic Hormone-Refractory Prostate Cancer|
|Actual Study Start Date:||September 1998|
|Study Completion Date:||March 2000|
|Primary Completion Date:||March 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the complete and partial remission rates and event free and overall survival of patients with metastatic hormone refractory prostate cancer treated with high dose chemotherapy plus peripheral stem cell transplantation followed by consolidation chemotherapy. II. Evaluate the toxic effects associated with this treatment in these patients. III. Evaluate the quality of life, and need for analgesics, in these patients.
OUTLINE: Patients are stratified by stage of disease and extent of metastatic disease. Patients receive daily filgrastim (G-CSF) subcutaneously for 4 days until peripheral blood stem cells are collected. Patients then receive carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1. Stem cell infusion will be on day 0. At 3, 6, 9, and 12 months after transplant, patients receive vinorelbine IV over 10 minutes and cisplatin IV over 24 hours. Quality of life and pain are assessed before the transplantation, just before discharge after transplantation, prior to each consolidation course, and then at 3, 6, and 12 months after the final course of chemotherapy. Patients are followed at least every 3 months for the first 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003400
|United States, Maryland|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Study Chair:||Guido J. Tricot, MD, PhD||University of Maryland Greenebaum Cancer Center|