Selumetinib in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
|Borderline Ovarian Surface Epithelial-stromal Tumor Ovarian Serous Cystadenocarcinoma Primary Peritoneal Cavity Cancer Recurrent Borderline Ovarian Surface Epithelial-stromal Tumor||Drug: selumetinib Other: pharmacological study Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of AZD6244 (NSC #748727) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum|
- Tumor Response [ Time Frame: Every other cycle ]Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0
- 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 ]
|Study Start Date:||December 2007|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (selumetinib)
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.
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
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.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551070
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|Principal Investigator:||John Farley||Gynecologic Oncology Group|