Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
- Conditions
- Ovarian CancerTesticular Germ Cell Tumor
- Registration Number
- NCT00003518
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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 II trial to study the effectiveness of paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell tumors that have not responded to surgery or chemotherapy.
- Detailed Description
OBJECTIVES: I. Evaluate the effect of gemcitabine plus paclitaxel on response rate, duration of remission, and survival in patients with refractory germ cell tumors. II. Evaluate the toxic effects of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1, 8, and 15 of each 4 week course. Treatment is repeated for a maximum of six courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 44 patients will be accrued over 19 months for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Pretoria Academic Hospital
🇿🇦Pretoria, South Africa
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
🇺🇸Chicago, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Kimball Medical Center
🇺🇸Lakewood, New Jersey, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States