Spots Global Cancer Trial Database for Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
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Trial Identification
Brief Title: Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
Official Title: Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma
Study ID: NCT00005861
Conditions
Interventions
Study Description
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 liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV endometrial cancer.
Detailed Description: OBJECTIVES: * Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer. * Determine the response rate, response duration, and overall survival of these patients treated with this regimen. OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Chao Family Comprehensive Cancer Center, Orange, California, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Brookview Research, Inc., Nashville, Tennessee, United States
Contact Details
Name: Howard D. Homesley, MD
Affiliation: Gynecologic Oncology Network
Role: STUDY_CHAIR
Name: Paula M. Fracasso, MD, PhD
Affiliation: Washington University Siteman Cancer Center
Role:
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