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