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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

🇺🇸

Los Angeles, California, United States

Riverside Methodist Hospital Cancer Care

🇺🇸

Columbus, Ohio, United States

Hinsdale Hematology Oncology Associates

🇺🇸

Hinsdale, Illinois, United States

Hulston Cancer Center at Cox Medical Center South

🇺🇸

Springfield, Missouri, United States

David L. Rike Cancer Center at Miami Valley Hospital

🇺🇸

Dayton, Ohio, United States

Rosenfeld Cancer Center at Abington Memorial Hospital

🇺🇸

Abington, Pennsylvania, United States

St. John's Regional Health Center

🇺🇸

Springfield, Missouri, United States

Alamance Cancer Center at Alamance Regional Medical Center

🇺🇸

Burlington, North Carolina, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

🇺🇸

Dallas, Texas, United States

St. Vincent Indianapolis Hospital

🇺🇸

Indianapolis, Indiana, United States

Oklahoma University Cancer Institute

🇺🇸

Oklahoma City, Oklahoma, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

Holden Comprehensive Cancer Center at University of Iowa

🇺🇸

Iowa City, Iowa, United States

West Michigan Cancer Center

🇺🇸

Kalamazoo, Michigan, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

University of Mississippi Cancer Clinic

🇺🇸

Jackson, Mississippi, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

Case Comprehensive Cancer Center

🇺🇸

Cleveland, Ohio, United States

SUNY Downstate Medical Center

🇺🇸

Brooklyn, New York, United States

Lake/University Ireland Cancer Center

🇺🇸

Mentor, Ohio, United States

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

Cancer Care Associates - Midtown Tulsa

🇺🇸

Tulsa, Oklahoma, United States

Avera Cancer Institute

🇺🇸

Sioux Falls, South Dakota, United States

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