A Trial for Patients With Gestational Trophoblastic Disease

A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor

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.

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