Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy
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|ClinicalTrials.gov Identifier: NCT00096187|
Recruitment Status : Terminated
First Posted : November 9, 2004
Last Update Posted : April 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Gestational Trophoblastic Tumor||Drug: pemetrexed disodium||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||July 23, 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096187
|Study Chair:||David S. Miller, MD||Simmons Cancer Center|
|OverallOfficial:||Allan Covens, MD||Toronto Sunnybrook Regional Cancer Centre|