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Brief Title: Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Official Title: A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
Study ID: NCT00030472
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 liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.
Detailed Description: OBJECTIVES: * Determine the antitumor activity of doxorubicin HCl liposome in patients with persistent or recurrent squamous cell carcinoma of the cervix. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Community Hospital of Los Gatos, Los Gatos, California, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
Tufts - New England Medical Center, Boston, Massachusetts, United States
Cooper University Hospital, Camden, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas M.D. Anderson CCOP Research Base, Houston, Texas, United States
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont, United States
Norwegian Radium Hospital, Oslo, , Norway
Name: Peter G. Rose, MD
Affiliation: MetroHealth Cancer Care Center at MetroHealth Medical Center
Role: STUDY_CHAIR