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 Toxicity Antitumor activity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Scroll for more (25 remaining)Hinsdale Hematology Oncology Associates🇺🇸Hinsdale, Illinois, United States