Phase II Study of Paclitaxel Plus Gemcitabine in Refractory Germ Cell Tumors
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.
Interventional
Primary Purpose: Treatment
Lawrence H. Einhorn, MD
Study Chair
Indiana University Melvin and Bren Simon Cancer Center
United States: Food and Drug Administration
CDR0000066562
NCT00003518
January 1999
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Kimball Medical Center | Lakewood, New Jersey 08701 |