Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
|ClinicalTrials.gov Identifier: NCT00005861|
Recruitment Status : Completed
First Posted : May 19, 2003
Last Update Posted : June 10, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma|
|Study Start Date :||May 2000|
|Primary Completion Date :||August 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005861
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Iowa|
|Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242-1009|
|United States, Massachusetts|
|New England Medical Center Hospital|
|Boston, Massachusetts, United States, 02111|
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216-4505|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|United States, Tennessee|
|Brookview Research, Inc.|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||Howard D. Homesley, MD||Gynecologic Oncology Network|
|OverallOfficial:||Paula M. Fracasso, MD, PhD||Washington University Siteman Cancer Center|