Brief Title
A Trial for Patients With Advanced/Recurrent Endometrial Cancer
Official Title
A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma
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 treating patients with advanced or recurrent endometrial carcinoma.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumor Response
Secondary Outcome
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Condition
Neoplasms
Intervention
pemetrexed
Study Arms / Comparison Groups
Pemetrexed
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
September 2006
Completion Date
September 2008
Primary Completion Date
October 2007
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
David Miller, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00377520
Organization ID
8368
Secondary IDs
H3E-US-JMGT
Study Sponsor
Eli Lilly and Company
Collaborators
Gynecologic Oncology Group
Study Sponsor
David Miller, MD, Study Chair, Gynecologic Oncology Group
Verification Date
November 2009