Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix
- Conditions
- Cervical Cancer
- Registration Number
- NCT00087113
- 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 cancer of the cervix.
- Detailed Description
OBJECTIVES:
* Determine the antitumor activity of pemetrexed disodium in patients with recurrent carcinoma of the cervix 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: Approximately 22-60 patients will be accrued for this study within 1-2 years.
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 Antitumor activity Toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Williamette Gynecologic Oncology P.C.
🇺🇸Salem, Oregon, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Doctors Medical Center
🇺🇸Modesto, California, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Cancer Care Associates - Midtown Tulsa
🇺🇸Tulsa, Oklahoma, United States
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Women's Cancer Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, 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