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Brief Title: Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
Official Title: A Phase II Evaluation of Weekly Topotecan Hydrochloride (Hycamtin®, NSC #609699) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix
Study ID: NCT00087126
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as topotecan, 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 topotecan works in treating women with persistent or recurrent cervical cancer.
Detailed Description: OBJECTIVES: * Determine the antitumor activity of topotecan in patients with persistent or 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 topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient are followed for every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama, United States
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Olive View - UCLA Medical Center Foundation, Sylmar, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain, Connecticut, United States
Yale Cancer Center, New Haven, Connecticut, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Saint Louis University Cancer Center, Saint Louis, Missouri, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa, Tulsa, Oklahoma, United States
Women and Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Name: James V. Fiorica, MD
Affiliation: Sarasota Memorial Hospital
Role: STUDY_CHAIR