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Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer

Phase 2
Completed
Conditions
Endometrial Cancer
Registration Number
NCT00087100
Lead Sponsor
Gynecologic Oncology Group
Brief Summary

RATIONALE: Drugs used in chemotherapy such as pemetrexed disodium work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with persistent or recurrent endometrial cancer.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of pemetrexed disodium in patients with persistent or recurrent endometrial adenocarcinoma that failed higher priority treatment protocols.

* Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 1-3.4 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
51
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Antitumor activity
Toxicity
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (23)

Jonsson Comprehensive Cancer Center at UCLA

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Hinsdale Hematology Oncology Associates

πŸ‡ΊπŸ‡Έ

Hinsdale, Illinois, United States

CCOP - Carle Cancer Center

πŸ‡ΊπŸ‡Έ

Urbana, Illinois, United States

St. Vincent Indianapolis Hospital

πŸ‡ΊπŸ‡Έ

Indianapolis, Indiana, United States

Holden Comprehensive Cancer Center at University of Iowa

πŸ‡ΊπŸ‡Έ

Iowa City, Iowa, United States

Massachusetts General Hospital

πŸ‡ΊπŸ‡Έ

Boston, Massachusetts, United States

West Michigan Cancer Center

πŸ‡ΊπŸ‡Έ

Kalamazoo, Michigan, United States

University of Mississippi Cancer Clinic

πŸ‡ΊπŸ‡Έ

Jackson, Mississippi, United States

St. John's Regional Health Center

πŸ‡ΊπŸ‡Έ

Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

πŸ‡ΊπŸ‡Έ

Springfield, Missouri, United States

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Jonsson Comprehensive Cancer Center at UCLA
πŸ‡ΊπŸ‡ΈLos Angeles, California, United States

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