A Trial for Patients With Advanced/Recurrent Endometrial Cancer

Neoplasms Clinical Trial

Official title:

A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma

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

Related Conditions & MeSH terms

• Cancer of Endometrium
• Cancer of the Endometrium
• Endometrial Cancer
• Endometrial Neoplasms
• Endometrium Cancer
• Genital Neoplasms, Female
• Neoplasms
• Neoplasms by Site
• Neoplasms, Endometrial
• Urogenital Neoplasms
• Uterine Neoplasms

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

External Links

•   Lilly Clinical Trial Registry