Selumetinib in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
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
Borderline Ovarian Surface Epithelial-stromal Tumor
Ovarian Serous Cystadenocarcinoma
Primary Peritoneal Cavity Cancer
Recurrent Borderline Ovarian Surface Epithelial-stromal Tumor
Genetic: mutation analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of AZD6244 (NSC #748727, IND #77782) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum|
- Tumor response rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact, up to 10 years ] [ Designated as safety issue: No ]Progression free survival will be estimated and graphed using the Kaplan-Meier product-limit method.
- Overall survival [ Time Frame: From entry into the study to death or the date of last contact, up to 10 years ] [ Designated as safety issue: No ]Overall survival will be estimated and graphed using the Kaplan-Meier product-limit method.
- Frequency and severity of adverse effects assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2007|
|Estimated Primary Completion Date:||January 2100 (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:Genetic: mutation analysis
Correlative studiesGenetic: protein expression analysis
Correlative studiesOther: immunohistochemistry staining method
Other Name: immunohistochemistryOther: pharmacological study
Other Name: pharmacological studies
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.