Spots Global Cancer Trial Database for Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
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Trial Identification
Brief Title: Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
Official Title: A Phase II Trial of AZD6244 (NSC# 748727) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum
Study ID: NCT00551070
Study Description
Brief Summary: This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To examine the tumor response rate of patients on AZD6244 (selumetinib sulfate) (NSC #748727). II. To examine the acute toxicity of AZD6244 (NSC #748727) during the first course of treatment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. III. To define the pharmacokinetic profile for AZD6244, 100 mg administered orally twice daily. SECONDARY OBJECTIVES: I. To examine the toxicity of AZD6244 (NSC #748727) using the 21 major categories of the CTCAE version 3.0. II. To examine the dose and number of courses of AZD6244 (NSC #748727) given. III. To estimate the progression free survival, and overall survival of women receiving AZD6244 (NSC #748727). TRANSLATIONAL RESEARCH OBJECTIVES: I. To examine deoxyribonucleic acid (DNA) isolation with sequencing of braf, and ras mutation analysis and to explore their relationship with tumor response with AZD6244 (NSC #748727). II. To examine protein levels of phosphorylated (p)-ERK/ERKERK) and explore their relationship with tumor response in patients treated with AZD6244 (NSC #748727). OUTLINE: Patients receive selumetinib sulfate orally (PO) twice a day (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection periodically for correlative and pharmacokinetic studies and to analyze selumetinib sulfate peak concentrations and the corresponding peak time values. Previously collected archived tumor tissue samples are obtained to determine protein levels of p-ERK/ERKERK, DNA isolation and sequencing of BRAF and ras mutation analysis by immunohistochemistry (IHC). After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year for 5 years.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Hartford Hospital, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
Christiana Care - Union Hospital, Elkton, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Bronson Battle Creek, Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, United States
Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, United States
Mercy Health Saint Mary's, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
Holland Community Hospital, Holland, Michigan, United States
Mercy Health Partners-Hackley Campus, Muskegon, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Metro Health Hospital, Wyoming, 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
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Gynecologic Oncology Network, Greenville, 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
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Miami Valley Hospital, Dayton, 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
M D Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: John H Farley
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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