A Trial for Patients With Gestational Trophoblastic Disease
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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