This phase II trial studies how well sunitinib malate works in treating patients with endometrial cancer that has come back after a period of improvement (recurrent) or has spread to other places in the body (metastatic). 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.
PRIMARY OBJECTIVES: I. To assess the objective response rate of recurrent or metastatic endometrial cancer to sunitinib (sunitinib malate). II. To assess the frequency of prolonged stable disease (as defined by percentage \[%\] of patients alive and free from progressive disease at 6 months) in patients with recurrent or metastatic endometrial cancer treated with sunitinib. SECONDARY OBJECTIVES: I. To assess time-to- progression, median overall survival, and rate of one-year survival in patients with recurrent or metastatic endometrial cancer treated with sunitinib. II. To assess the toxicity associated with sunitinib in patients with recurrent or metastatic endometrial cancer. OUTLINE: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed up at 4 weeks and then every 3 months until relapse.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Given PO
Tower Cancer Research Foundation
Beverly Hills, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Objective Response Rate
Objective response rate, defined as the rate of complete or partial response as defined by the Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), disappearance of all target lesions.
Time frame: Up to 7 years
Number of Participants With Prolonged Stable Disease
Described as the best response of stable disease that is maintained for atleast 6 months
Time frame: Up to 7 years
Overall Survival
Estimated using the Kaplan-Meier method.
Time frame: Up to 7 years
Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0
Number of participants that experience at east 1 adverse event while on trial, according to the CTCAE.
Time frame: Up to 7 years
Time to Progression
The length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body. Assessed by Kaplan and Meier method
Time frame: Up to 7 years
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