Spots Global Cancer Trial Database for Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix
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Trial Identification
Brief Title: Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix
Official Title: A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix
Study ID: NCT00087113
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Doctors Medical Center, Modesto, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Women's Cancer Center - Las Vegas, Las Vegas, Nevada, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Hope A Women's Cancer Center, Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights, Ohio, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa, Tulsa, Oklahoma, United States
Williamette Gynecologic Oncology P.C., Salem, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, United States
Contact Details
Name: David S. Miller, MD
Affiliation: Simmons Cancer Center
Role: STUDY_CHAIR
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