A Trial for Patients With Gestational Trophoblastic Disease

Lilly

Status and phase

Completed

Phase 2

Conditions

Choriocarcinoma

Uterine Neoplasms

Hydatidiform Mole

Trophoblastic Neoplasms

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00190918

8366

H3E-US-JMGR

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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