Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||August 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|