NCT00551070

Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To examine the tumor response rate of patients on AZD6244 (selumetinib sulfate) (NSC #748727). II. To examine the acute toxicity of AZD6244 (NSC #748727) during the first course of treatment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 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). TRANSLATIONAL RESEARCH OBJECTIVES: I. To examine deoxyribonucleic acid (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 phosphorylated (p)-ERK/ERKERK) and explore their relationship with tumor response in patients treated with AZD6244 (NSC #748727). OUTLINE: Patients receive selumetinib sulfate orally (PO) twice a day (BID) on days 1-28. Cycles 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 sulfate 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.

Conditions

• Borderline Ovarian Serous Tumor
• Low Grade Ovarian Serous Adenocarcinoma
• Micropapillary Serous Carcinoma
• Primary Peritoneal Carcinoma
• Primary Peritoneal Low Grade Serous Adenocarcinoma
• Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Selumetinib	Given PO
DRUG	Selumetinib Sulfate	Given PO

Timeline

• Start date: 2007-12-17
• Primary completion: 2013-07-23
• Completion: 2020-11-13
• First posted: 2007-10-30
• Last updated: 2020-12-03
• Results posted: 2015-06-29

Locations

49 sites across 1 country: United States