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A Trial for Patients With Advanced/Recurrent Endometrial Cancer

NCT ID: NCT00377520

Last Updated: 2009-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pemetrexed

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

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

Interventions

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pemetrexed

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

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gynecologic Oncology Group

NETWORK

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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David Miller, MD

Role: STUDY_CHAIR

Gynecologic Oncology Group

Locations

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Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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H3E-US-JMGT

Identifier Type: -

Identifier Source: secondary_id

8368

Identifier Type: -

Identifier Source: org_study_id