Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients age greater than 18 with the following tumors are included in the study:

Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by Gynecologic Oncology Group [GOG], International Federation of Gynecology and Obstetrics [FIGO] World Health Organization [WHO] or Silverberg)
Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)

Patients must have measurable disease:

Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each "target" lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT

Patient must have documented low grade serous carcinoma (invasive micropapillary serous); confirmation must occur before patient is considered eligible for the trial

Patients whose primary tumor was low-grade serous ovarian or peritoneal carcinoma must have a pretreatment sample of their tumor from their primary or recurrent tumor that documents low grade serous carcinoma (invasive micropapillary serous)
Patients whose primary tumor was serous borderline ovarian or peritoneal carcinoma must have a pretreatment sample of their tumor from their recurrent tumor that documents low grade serous carcinoma (invasive micropapillary serous)
Creatinine CTCAE grade 0-1 (< 1.5 x upper limit of normal [ULN])
Bilirubin CTCAE grade 0-1 (< 1.5 x ULN)
Transaminases CTCAE grade 0-1 (< 2.5 x ULN)
Neutrophil CTCAE grade 0-1 (>= 1500/mcl)
Platelets CTCAE grade 0-1 (>= 100,000/mcl)
Neuropathy =< CTCAE grade 1
No restrictions on prior therapy; patients cannot have previously received AZD6244
Patients of childbearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control prior to study entry, for the duration of study participation, and for four weeks after dosing with AZD6244 ceases
Patients who have met the pre-entry requirements
Patients must have signed an approved informed consent and authorization permitting release of personal health information
Patients must have a GOG performance status of 0 or 1

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients may not be receiving any other investigational agents
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 or its excipient Captisol
Previous mitogen-activated protein kinase (MEK) inhibitor use
Patients with corrected QT (QTc) interval > 450 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded
Required use of a concomitant medication that can prolong the QT interval
Patients should not receive any drugs known to affect or with the potential to affect selected CYP450 isoenzymes
Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because the effects of AZD6244 on the developing human fetus at the recommended therapeutic dose are unknown; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with AZD6244
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD6244; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

52

Study ID:

NCT00551070

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 45 Locations for this study

See Locations Near You

USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Stanford Cancer Institute Palo Alto
Palo Alto California, 94304, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain Connecticut, 06050, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale Illinois, 60521, United States
Saint Vincent Hospital and Health Care Center
Indianapolis Indiana, 46260, United States
Maine Medical Center-Bramhall Campus
Portland Maine, 04102, United States
Christiana Care - Union Hospital
Elkton Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Bronson Battle Creek
Battle Creek Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids Michigan, 49307, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
Holland Community Hospital
Holland Michigan, 49423, United States
Mercy Health Partners-Hackley Campus
Muskegon Michigan, 49442, United States
Mercy Health Mercy Campus
Muskegon Michigan, 49444, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Metro Health Hospital
Wyoming Michigan, 49519, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Cancer Research for the Ozarks NCORP
Springfield Missouri, 65804, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CoxHealth South Hospital
Springfield Missouri, 65807, United States
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Gynecologic Oncology Network
Greenville North Carolina, 27834, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Mount Carmel Health Center West
Columbus Ohio, 43222, United States
Miami Valley Hospital
Dayton Ohio, 45409, United States
Hillcrest Hospital Cancer Center
Mayfield Heights Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa Oklahoma, 74146, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

52

Study ID:

NCT00551070

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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