This trial is active, not recruiting.

Conditions borderline ovarian surface epithelial-stromal tumor, ovarian serous cystadenocarcinoma, primary peritoneal cavity cancer, recurrent borderline ovarian surface epithelial-stromal tumor
Treatments selumetinib, pharmacological study, laboratory biomarker analysis
Phase phase 2
Target MEK
Sponsor National Cancer Institute (NCI)
Start date December 2007
End date July 2013
Trial size 51 participants
Trial identifier NCT00551070, CDR0000563965, GOG-0239, NCI-2009-00604, U10CA027469


This phase II trial is studying the side effects and how well selumetinib works in treating patients with recurrent low-grade ovarian cancer. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients receive selumetinib PO twice a day on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
selumetinib ARRY-142886
Given PO
pharmacological study pharmacological studies
Correlative studies
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Tumor response rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Up to 10 years

Secondary Outcomes

Progression-free survival
time frame: From study entry until disease progression, death or date of last contact, up to 10 years
Overall survival
time frame: From entry into the study to death or the date of last contact, up to 10 years
Frequency and severity of adverse effects assessed by Common Terminology Criteria for Adverse Events version 3.0
time frame: Up to 10 years

Eligibility Criteria

Female participants at least 19 years old.

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 requirements - 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 isoenzymes - No concurrent grapefruit or grapefruit juice during AZD6244 administration - No other concurrent investigational or commercial agents for this cancer

Additional Information

Official title A Phase II Trial of AZD6244 (NSC #748727) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum
Principal investigator John Farley
Description PRIMARY OBJECTIVES: 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 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). TERTIARY OBJECTIVES: 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).