Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
|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: NCT00378911|
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : June 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Uterine Sarcoma Uterine Leiomyosarcoma||Drug: sunitinib malate||Phase 2|
I. Assess the activity of sunitinib malate, in terms of rate of progression-free survival for ≥ 6 months and objective tumor response, in patients with recurrent or persistent leiomyosarcoma of the uterus who have received 1 or 2 prior cytotoxic therapies.
II. Determine the frequency and severity of adverse events.
I. Determine the duration of progression-free survival and overall survival.
OUTLINE: This is a multicenter study. Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Sunitinib Malate (Sutent®, SU11248, NCI-Supplied Agent , NSC # 736511) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||January 2010|
Experimental: Treatment (sunitinib malate)
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
- Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact., assessed up to 6 months ]
- Objective tumor response according to GOG RECIST criteria [ Time Frame: Up to 5 years ]
- Frequency and severity of adverse events as assessed by CTCAE v 3.0 [ Time Frame: Up to 5 years ]The frequency and severity of all toxicities will be tabulated.
- Duration of progression-free survival [ Time Frame: Up to 5 years ]Characterized graphically and using descriptive statistics such as median survival.
- Duration of overall survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]Characterized graphically and using descriptive statistics such as median survival.
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): NCT00378911
|United States, Pennsylvania|
|Gynecologic Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Martee Hensley||Gynecologic Oncology Group|