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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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
Tumor Response
Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0
Time frame: Every other cycle
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Time frame: Cycle 1
Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.
Time frame: Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment
Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.
Time frame: Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment
Progression-free Survival
Time frame: Every other cycle
Number of Courses Received
Time frame: Every cycle
Overall Survival
Time frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years
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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
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