Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
- Conditions
- Primary Peritoneal Cavity CancerOvarian Cancer
- Registration Number
- NCT00087087
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
- Detailed Description
OBJECTIVES:
* Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols.
* Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antitumor activity Toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
🇺🇸Knoxville, Tennessee, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
UMDNJ University Hospital
🇺🇸Newark, New Jersey, United States
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Women's Cancer Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Stony Brook University Cancer Center
🇺🇸Stony Brook, New York, United States
Williamette Gynecologic Oncology PC
🇺🇸Salem, Oregon, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Cancer Care Associates - Midtown Tulsa
🇺🇸Tulsa, Oklahoma, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States