Spots Global Cancer Trial Database for Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
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Trial Identification
Brief Title: Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
Official Title: A Phase 2 Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma
Study ID: NCT00478426
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Evanston Hospital CCOP, Evanston, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard, Fort Wayne, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Oncology Care Associates PLLC, Saint Joseph, Michigan, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus, Ottawa, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Contact Details
Name: Amit M Oza
Affiliation: University Health Network-Princess Margaret Hospital
Role: PRINCIPAL_INVESTIGATOR
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