Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
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|