A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix
- 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
Masking: Open Label, Primary Purpose: Treatment
David S. Miller, MD
Simmons Cancer Center
United States: Federal Government
|CCOP - Kansas City||Kansas City, Missouri 64131|
|Hinsdale Hematology Oncology Associates||Hinsdale, Illinois 60521|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44106|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Doctors Medical Center||Modesto, California 95350|
|St. John's Regional Health Center||Springfield, Missouri 65804|
|Women's Cancer Center - Las Vegas||Las Vegas, Nevada 89102|
|SUNY Downstate Medical Center||Brooklyn, New York 11203|
|Oklahoma University Medical Center||Oklahoma City, Oklahoma 73104|
|Cancer Care Associates - Midtown Tulsa||Tulsa, Oklahoma 74104|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Massey Cancer Center at Virginia Commonwealth University||Richmond, Virginia 23298-0037|
|Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center||Hartford, Connecticut 06105|
|Hope A Women's Cancer Center||Asheville, North Carolina 28801|
|Hillcrest Cancer Center at Hillcrest Hospital||Mayfield Heights, Ohio 44124|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest||Allentown, Pennsylvania 18105|
|Williamette Gynecologic Oncology P.C.||Salem, Oregon 97301|