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Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus

Phase 2
Terminated
Conditions
Sarcoma
Registration Number
NCT00003316
Lead Sponsor
Gynecologic Oncology Group
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.

Detailed Description

OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Recruitment & Eligibility

Status
TERMINATED
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
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (40)

University of Alabama Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

CCOP - Greater Phoenix

🇺🇸

Phoenix, Arizona, United States

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center

🇺🇸

Orange, California, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Rush-Presbyterian-St. Luke's Medical Center

🇺🇸

Chicago, Illinois, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Indiana University Cancer Center

🇺🇸

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, United States

Scroll for more (30 remaining)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

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