A Trial for Patients With Gestational Trophoblastic Disease

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Gynecologic Oncology Group
• Treatments: Pemetrexed

Criteria

Inclusion Criteria:

• Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)

• WHO score 2-6 (re-evaluated at the time of relapse

• Histologically confirmed complete or partial moles on initial evacuation

• Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.

• All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.

• Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.

• Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy.

Exclusion Criteria:

• Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid).

• Patients with more than 8 metastatic lesions identified

• Patients with metastases to liver, spleen, brain, kidney or GI tract