Clinical Trial: Selumetinib in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Tumor response rate (complete and partial response)

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Progression-free Survival
  • Overall survival
  • Toxicity as assessed by CTCAE version 3.0
  • Relationship of tumor response rate with DNA isolation and sequencing of BRAF and ras mutation analysis
  • Levels of BRAF and ras mutation in the tumor
  • Protein levels of p-ERK/ERKERK
  • Pharmacokinetic profile of AZD6244


Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 22, 2007
Date Started: December 2007
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016