Chemotherapy in Treating Patients With Sarcoma of the Uterus
|ClinicalTrials.gov Identifier: NCT00005643|
Recruitment Status : Completed
First Posted : April 19, 2004
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 patients who have advanced or recurrent sarcoma of the uterus.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Sarcoma||Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
OBJECTIVES: I. Estimate the antitumor activity of doxorubicin HCl liposome in patients with recurrent or advanced uterine sarcoma. II. Determine the nature and degree of toxicity of this drug in this patient population.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1-1.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus|
|Study Start Date :||May 2000|
|Actual Primary Completion Date :||March 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005643
Show 49 Study Locations
|Study Chair:||Gregory P. Sutton, MD||Indiana University Melvin and Bren Simon Cancer Center|