Status:
COMPLETED
A Trial for Patients With Advanced/Recurrent Endometrial Cancer
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Gynecologic Oncology Group
Conditions:
Neoplasms
Neoplasms by Site
Eligibility:
FEMALE
Phase:
PHASE2
Brief 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 tr...
Eligibility Criteria
Inclusion
- 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
- Patients who have had prior therapy with Pemetrexed
- Patients who have received radiation to more than 25% of marrow bearing areas
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00377520
Start Date
September 1 2006
End Date
September 1 2008
Last Update
November 20 2009
Active Locations (1)
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1
Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, United States, 19103