Sunitinib in Treating Patients With Recurrent or Metastatic Endometrial Cancer
This phase II trial is studying how well sunitinib works in treating patients with recurrent or metastatic endometrial cancer. 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.
Endometrial Papillary Serous Carcinoma
Recurrent Endometrial Carcinoma
Recurrent Uterine Sarcoma
Stage IV Endometrial Carcinoma
Stage IV 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 2 Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma|
- Objective response rate (complete or partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Percentage of patients alive and free from progressive disease assessed by RECIST [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Frequency and severity of observed adverse effects assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
- Time to progression assessed by RECIST [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive sunitinib malate PO QD on days 1-28.
Drug: sunitinib malate
I. Determine the objective response rate in patients with recurrent or metastatic endometrial cancer treated with sunitinib malate.
II. Determine the frequency of prolonged stable disease (as defined by percentage of patients alive and free from progressive disease at 6 months) in patients treated with this drug.
I. Determine time to progression, median overall survival, and rate of one-year survival in patients treated with this drug.
II. Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed at 4 weeks.
|United States, California|
|Tower Cancer Research Foundation|
|Beverly Hills, California, United States, 90211-1850|
|City of Hope|
|Duarte, California, United States, 91010|
|USC Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|City of Hope Medical Group Inc|
|Pasadena, California, United States, 91105|
|UC Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA-Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|
|Ottawa General Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Odette Cancer Centre- Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Principal Investigator:||Amit Oza||University Health Network-Princess Margaret Hospital|