Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy
- Conditions
- Ovarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00006028
- Lead Sponsor
- Gynecologic 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 gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
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 (31)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Ellis Fischel Cancer Center
🇺🇸Indianapolis, Indiana, United States
CCOP - M.D. Anderson Research Base
🇺🇸Houston, Texas, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Tuft-New England Medical Center
🇺🇸Boston, Massachusetts, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Norwegian Radium Hospital
🇳🇴Oslo, Norway
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States