Gestational Trophoblastic Tumor Clinical Trial
Official title:
A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
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 low-risk gestational trophoblastic tumor after a molar
pregnancy.
OBJECTIVES:
- 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
months.
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