Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer
OBJECTIVES:
- Determine the anti-tumor activity of gemcitabine and cisplatin in patients with
recurrent or refractory platinum-resistant ovarian epithelial cancer or primary
peritoneal carcinoma who have failed on higher priority treatment protocols.
- Determine the nature and degree of toxicity of this regimen in this patient population.
- Correlate ex vivo drug sensitivity and resistance with clinical response to this
regimen in these patients.
- Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo
measures of drug resistance in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1
and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease
progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14
months.
Interventional
Primary Purpose: Treatment
Cheryl A. Brewer, MD
Study Chair
University of Illinois College of Medicine at Peoria
United States: Federal Government
CDR0000068041
NCT00006028
January 2001
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Community Hospital of Los Gatos | Los Gatos, California 95032 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Brookview Research, Inc. | Nashville, Tennessee 37203 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
Tuft-New England Medical Center | Boston, Massachusetts 02111 |
CCOP - M.D. Anderson Research Base | Houston, Texas 77030-4009 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
Ellis Fischel Cancer Center | Indianapolis, Indiana 46285 |