Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
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|ClinicalTrials.gov Identifier: NCT00551070|
Recruitment Status : Active, not recruiting
First Posted : October 30, 2007
Results First Posted : June 29, 2015
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Borderline Ovarian Epithelial Tumor Low Grade Ovarian Serous Adenocarcinoma Primary Peritoneal Carcinoma Primary Peritoneal Low Grade Serous Adenocarcinoma Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor||Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Selumetinib Sulfate||Phase 2|
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 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 deoxyribonucleic acid (DNA) isolation with sequencing of b-raf proto-oncogene, serine/threonine kinase (braf), and retrovirus associated sequence (ras) mutation analysis and to explore their relationship with tumor response with AZD6244 (NSC #748727).
II. To examine protein levels of phosphorylated mitogen-activated protein kinase 1 (p-ERK/ERKERK) and explore their relationship with tumor response in patients treated with AZD6244 (NSC #748727).
Patients receive selumetinib sulfate orally (PO) twice a day (BID) 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of AZD6244 (NSC# 748727) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum|
|Actual Study Start Date :||December 17, 2007|
|Actual Primary Completion Date :||July 23, 2013|
Experimental: Treatment (selumetinib sulfate)
Patients receive selumetinib sulfate PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Selumetinib Sulfate
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551070
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|Principal Investigator:||John Farley||NRG Oncology|