A Trial for Patients With Gestational Trophoblastic Disease
Trophoblastic Neoplasms, Uterine Neoplasms, Hydatidiform Mole
About this trial
This is an interventional treatment trial for Trophoblastic Neoplasms
Eligibility 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
Sites / Locations
- Gynecologic Oncology Group 215-854-0770