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.
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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