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Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix

Phase 2
Completed
Conditions
Cervical Cancer
Registration Number
NCT00087113
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 recurrent cancer of the cervix.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of pemetrexed disodium in patients with recurrent carcinoma of the cervix 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 22-60 patients will be accrued for this study within 1-2 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
Not specified
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 (22)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Doctors Medical Center

🇺🇸

Modesto, California, United States

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

🇺🇸

Hartford, Connecticut, United States

Hinsdale Hematology Oncology Associates

🇺🇸

Hinsdale, Illinois, United States

CCOP - Kansas City

🇺🇸

Kansas City, Missouri, United States

St. John's Regional Health Center

🇺🇸

Springfield, Missouri, United States

Women's Cancer Center - Las Vegas

🇺🇸

Las Vegas, Nevada, United States

SUNY Downstate Medical Center

🇺🇸

Brooklyn, New York, United States

SUNY Upstate Medical University Hospital

🇺🇸

Syracuse, New York, United States

Hope A Women's Cancer Center

🇺🇸

Asheville, North Carolina, United States

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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States

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