A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
- Determine the activity of pemetrexed disodium as salvage therapy in patients with
persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed
prior dactinomycin or methotrexate.
- Determine the 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 unacceptable toxicity or disease progression or until tumor marker
levels (human chorionic gonadotropin [hCG]) become normal. Patients receive 2 additional
courses beyond the attainment of a normal hCG.
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 2 weeks for 2 months and then monthly for 10 months.
PROJECTED ACCRUAL: Approximately 17-55 patients will be accrued for this study within 20-50
Masking: Open Label, Primary Purpose: Treatment
David S. Miller, MD
Simmons Cancer Center
United States: Food and Drug Administration
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Hinsdale Hematology Oncology Associates||Hinsdale, Illinois 60521|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Providence Saint Joseph Medical Center - Burbank||Burbank, California 91505|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Hulston Cancer Center at Cox Medical Center South||Springfield, Missouri 65807|
|St. John's Regional Health Center||Springfield, Missouri 65804|
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center||Orange, California 92868|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Hillcrest Cancer Center at Hillcrest Hospital||Mayfield Heights, Ohio 44124|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Wilson Medical Center||Wilson, North Carolina 27893-3428|
|UMC Southwest Cancer and Research Center||Lubbock, Texas 79415-3364|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham||Birmingham, Alabama 35294|