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A Phase II Trial of AZD6244 (NSC #748727, IND #77782) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Phase 2
19 Years
Open (Enrolling)
Borderline Ovarian Surface Epithelial-stromal Tumor, Ovarian Serous Cystadenocarcinoma, Primary Peritoneal Cavity Cancer, Recurrent Borderline Ovarian Surface Epithelial-stromal Tumor

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Trial Information

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
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.

Inclusion Criteria:

- Meeting 1 of the following diagnosis:

- Low-grade ovarian carcinoma that recurred as low-grade serous carcinoma
(invasive micropapillary serous carcinoma or invasive grade I serous carcinomas
as defined by GOG, FIGO WHO, or S. G. Silverberg) or peritoneal carcinoma

- Serous borderline ovarian carcinoma that recurred as low-grade serous carcinoma
(invasive micropapillary serous carcinoma or invasive grade I serous carcinomas
as defined by GOG, FIGO WHO, or S. G. Silverberg) or peritoneal carcinoma

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques including palpation, plain x-ray, CT scan, or MRI scan, OR ≥
10 mm by spiral CT scan

- Patients whose primary tumor was serous borderline ovarian carcinoma, low-grade
serous ovarian carcinoma, or peritoneal carcinoma must have a pretreatment sample of
their tumor from their primary or recurrent tumor that documents low grade serous
carcinoma (invasive micropapillary serous)

- No known brain metastases

- GOG performance status 0-1

- Platelet count ≥ 100,000/mm³

- ANC count ≥ 1,500/mm³

- Bilirubin < 1.5 times upper limit of normal (ULN)

- Creatinine < 1.5 times ULN

- Transaminases < 2.5 times ULN

- Neuropathy ≤ grade 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to, during, and for 4 weeks
after completion of study therapy

- QTc interval ≤ 450 msec and no factors that increase the risk of QT prolongation or
arrhythmic events including, but not limited to, any of the following:

- Heart failure

- Hypokalemia

- Family history of long QT interval syndrome

- NYHA class III-IV heart failure

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to AZD6244 or its excipient Captisol

- No refractory nausea and vomiting, chronic gastrointestinal diseases (e.g.,
inflammatory bowel disease), or significant bowel resection that would preclude
adequate absorption

- No uncontrolled intercurrent illness including ongoing or active infection,
psychiatric illness, or social situations that would limit compliance with study

- More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas
or mitomycin C) and recovered

- No prior AZD6244

- No prior MEK inhibitor

- No HIV-positive patients on combination antiretroviral therapy

- No concurrent medications with the potential to prolong the QT interval

- No concurrent drugs known to affect or with the potential to affect selected CYP450

- No concurrent grapefruit or grapefruit juice during AZD6244 administration

- No other concurrent investigational or commercial agents for this cancer

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Up to 10 years

Safety Issue:


Principal Investigator

John Farley

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

Related Keywords:

  • Borderline Ovarian Surface Epithelial-stromal Tumor
  • Ovarian Serous Cystadenocarcinoma
  • Primary Peritoneal Cavity Cancer
  • Recurrent Borderline Ovarian Surface Epithelial-stromal Tumor
  • Cystadenocarcinoma
  • Peritoneal Neoplasms
  • Cystadenocarcinoma, Serous
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



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