Spots Global Cancer Trial Database for Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer
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Trial Identification
Brief Title: Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer
Official Title: A Phase II Evaluation of SU11248 (Sunitinib Malate) (NSC #736511) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma
Study ID: NCT00979992
Study Description
Brief Summary: This phase II trial studies the side effects of sunitinib malate and how well it works in treating patients with ovarian cancer that is persistent or has come back. Sunitinib malate 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 evaluate the anti-tumor activity of SU11248 (sunitinib malate), a highly potent, selective tyrosine kinases inhibitor, in patients with persistent or recurrent clear cell ovarian carcinoma. II. To examine the nature and degree of toxicity in this cohort of patients treated with this regimen. SECONDARY OBJECTIVES: I. To characterize the distribution of progression-free survival and overall survival for patients treated with SU11248 (sunitinib malate). TERTIARY OBJECTIVES: I. To determine the pre-cycle 1, pre-cycle 4 and off-treatment levels of pro-angiogenic proteins (e.g., angiogenin, soluble vascular cell adhesion molecule \[VCAM\]-I, basic fibroblast growth factor \[bFGF\], platelet-derived growth factor \[PDGF\], placental growth factor \[PlGF\], vascular endothelial growth factor \[VEGF\], and hypoxia-inducible factor \[HIF\]1alpha). II. To identify changes in serum and plasma angiogenesis markers at baseline (pre-cycle 1), during treatment (cycle 4), and at progression in association with primary and secondary clinical endpoints associated with clinical response or progression-free survival. OUTLINE: Patients receive sunitinib malate orally (PO) once daily (QD) for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
John Muir Medical Center-Concord Campus, Concord, California, United States
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
John Muir Medical Center-Walnut Creek, Walnut Creek, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
AdventHealth Orlando, Orlando, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, United States
Elkhart Clinic, Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Community Howard Regional Health, Kokomo, Indiana, United States
IU Health La Porte Hospital, La Porte, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville, Westville, Indiana, United States
McFarland Clinic PC - Ames, Ames, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Beaumont Hospital - Dearborn, Dearborn, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Green Bay Oncology - Escanaba, Escanaba, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center, Grand Blanc, Michigan, United States
Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Lakeland Hospital Niles, Niles, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Lake Huron Medical Center, Port Huron, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, United States
Marie Yeager Cancer Center, Saint Joseph, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cancer Research for the Ozarks NCORP, Springfield, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Center of Hope at Renown Medical Center, Reno, Nevada, United States
Renown Regional Medical Center, Reno, Nevada, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Atrium Health Cabarrus/LCI-Concord, Concord, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Parkland Memorial Hospital, Dallas, Texas, United States
Clements University Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Keimyung University-Dongsan Medical Center, Jung-Ku, Daegu, Korea, Republic of
Samsung Medical Center, Seoul, Korea, Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Korea Cancer Center Hospital, Seoul, , Korea, Republic of
Contact Details
Name: John K Chan
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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