Overview

A Trial for Patients With Advanced/Recurrent Endometrial Cancer

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
Female
Summary
The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
Gynecologic Oncology Group
Treatments:
Pemetrexed
Criteria
Inclusion Criteria:

- 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
endometrial carcinoma.

- 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.

Exclusion Criteria:

- Patients who have had prior therapy with Pemetrexed

- Patients who have received radiation to more than 25% of marrow bearing areas