A Trial for Patients With Gestational Trophoblastic Disease

Phase 2

Completed

• Conditions: Trophoblastic Neoplasms; Uterine Neoplasms; Hydatidiform Mole; Choriocarcinoma

• Registration Number: NCT00190918
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Start: 2006-07
• Study Completion: 2007-07
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-07
• Last Update Posted: 2007-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

Secondary Outcome Measures

Name	Time	Method
To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

Trial Locations

Locations (1)

Gynecologic Oncology Group 215-854-0770; 🇺🇸 Philadelphia, Pennsylvania, United States