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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00377520
Other study ID # 8368
Secondary ID H3E-US-JMGT
Status Completed
Phase Phase 2
First received September 14, 2006
Last updated November 13, 2009
Start date September 2006
Est. completion date September 2008

Study information

Verified date November 2009
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date September 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression

Locations

Country Name City State
United States Gynecologic Oncology Group 215-854-0770 Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor Response baseline to measured progressive disease (up to 24 months) No
Secondary Number of Participants With Adverse Events by Grade (Measures of Toxicity) every 21-day cycle (up to 24 months) Yes
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