A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma
- Patients must have recurrent or persistent endometrial adenocarcinoma, which is
refractory to curative therapy or established treatments.
- Patients must have measurable disease.
- Patients must have had one prior chemotherapeutic regimen for management of
- Patients must have signed an approved informed consent.
- Patients of childbearing potential must have a negative serum pregnancy test prior to
the study entry and be practicing an effective form of contraception during the study
and for at least 3 months following the last dose of Pemetrexed.
- Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications 2-5
days prior to and for 1-2 days after receiving Pemetrexed, depending on the half-life
of the NSAIDs treatment.
- Patients must agree to this schedule in conjunction with every dose of Pemetrexed.
- Patients must receive 350-1000 mcg of folic acid (e.g. one prenatal vitamin) starting
7 days prior to the first treatment with Pemetrexed.
- Patients must be able to ingest 350-1000 mcg of folic acid daily until 3 weeks after
the last dose of Pemetrexed.
- Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the
dose, the day of and the day after every dose of Pemetrexed.
- Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the
first treatment with Pemetrexed.
- Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3
weeks after the last dose of Pemetrexed.
- Patients who have had prior therapy with Pemetrexed
- Patients who have received radiation to more than 25% of marrow bearing areas