NCT00096187

Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy

A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 120 Years
• Healthy volunteers: Not accepted

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 or persistent low-risk gestational trophoblastic tumor after a molar pregnancy.

Detailed description

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.

Conditions

• Gestational Trophoblastic Tumor

Interventions

Type	Name	Description
DRUG	pemetrexed disodium

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-07-23
• First posted: 2004-11-09
• Last updated: 2018-04-12

Locations

25 sites across 1 country: United States