A Trial for Patients With Advanced/Recurrent Endometrial Cancer

Completed · Phase 2

Conditions studied: Neoplasms, Neoplasms by Site, Urogenital Neoplasms, Genital Neoplasms, Female, Uterine Neoplasms, Endometrial Neoplasms, Cancer of Endometrium, Endometrial Cancer, Cancer of the Endometrium, Endometrium Cancer, Neoplasms, Endometrial

In brief

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.

Key facts

Study ID

NCT00377520

Run by

Eli Lilly and Company

People needed

27

Starts

2006-09-01

Expected to finish

2008-09-01

Last updated by the study team

2009-11-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients who have had prior therapy with Pemetrexed
• Patients who have received radiation to more than 25% of marrow bearing areas

Where it is running

• Gynecologic Oncology Group 215-854-0770 — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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