Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
Recurrent Uterine Sarcoma
Drug: sunitinib malate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact., assessed up to 6 months ] [ Designated as safety issue: No ]
- Objective tumor response according to GOG RECIST criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Frequency and severity of adverse events as assessed by CTCAE v 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]The frequency and severity of all toxicities will be tabulated.
- Duration of progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Characterized graphically and using descriptive statistics such as median survival.
|Study Start Date:||October 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378911
|United States, Pennsylvania|
|Gynecologic Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Martee Hensley||Gynecologic Oncology Group|