A Phase II Trial of AZD6244 (NSC #748727, IND #77782) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum
I. To examine the tumor response rate of patients on AZD6244 (selumetinib) (NSC #748727).
II. To examine the acute toxicity of AZD6244 (NSC #748727) during the first course of
treatment using CTCAE version 3.0.
III. To define the pharmacokinetic profile for AZD6244, 100 mg administered orally twice
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
I. To examine 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 p-ERK/ERKERK and explore their relationship with tumor
response in patients treated with AZD6244 (NSC #748727).
OUTLINE: This is a multicenter study.
Patients receive selumetinib orally (PO) twice a day on days 1-28. Courses 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 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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 10 years
Gynecologic Oncology Group
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Gynecologic Oncology Network||Greenville, North Carolina 27858|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Hartford Hospital||Hartford, Connecticut 06102-5037|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|MetroHealth Medical Center||Cleveland, Ohio 44109|
|Holland Community Hospital||Holland, Michigan 49423|
|Munson Medical Center||Traverse City, Michigan 49684|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Mecosta County Medical Center||Big Rapids, Michigan 49307|
|Miami Valley Hospital||Dayton, Ohio 45409|
|Metro Health Hospital||Grand Rapids, Michigan 49506|
|Riverside Methodist Hospital||Columbus, Ohio 43214|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|M D Anderson Cancer Center||Houston, Texas 77030|
|University of Southern California||Los Angeles, California 90033|
|The Hospital of Central Connecticut||New Britain, Connecticut 06050|
|Saint Vincent Hospital and Health Services||Indianapolis, Indiana 46260|
|Grand Rapids Clinical Oncology Program||Grand Rapids, Michigan 49503|
|Saint Mary's Health Care||Grand Rapids, Michigan 49503|
|Spectrum Health at Butterworth Campus||Grand Rapids, Michigan 49503|
|Mercy Health Partners-Mercy Campus||Muskegon, Michigan 49443|
|Mercy Health Partners-Hackley Campus||Muskegon, Michigan 49442|
|Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield||Springfield, Missouri 65802|
|Mount Carmel Health Center West||Columbus, Ohio 43222|
|Cancer Care Associates-Yale||Tulsa, Oklahoma 74136-1929|
|Cancer Care Associates-Midtown||Tulsa, Oklahoma 74104|
|Maine Medical Center-Bramhall Campus||Portland, Maine 04102|
|Stanford University Hospitals and Clinics||Stanford, California 94305|
|Bronson Battle Creek||Battle Creek, Michigan 49017|