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.
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.
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
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There are 45 Locations for this study
Los Angeles California, 90033, United States
Palo Alto California, 94304, United States
Hartford Connecticut, 06102, United States
New Britain Connecticut, 06050, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Chicago Illinois, 60637, United States
Hinsdale Illinois, 60521, United States
Indianapolis Indiana, 46260, United States
Portland Maine, 04102, United States
Elkton Maryland, 21921, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Battle Creek Michigan, 49017, United States
Big Rapids Michigan, 49307, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Holland Michigan, 49423, United States
Muskegon Michigan, 49442, United States
Muskegon Michigan, 49444, United States
Traverse City Michigan, 49684, United States
Wyoming Michigan, 49519, United States
Jackson Mississippi, 39216, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Camden New Jersey, 08103, United States
New York New York, 10065, United States
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28204, United States
Greenville North Carolina, 27834, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43222, United States
Dayton Ohio, 45409, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Abington Pennsylvania, 19001, United States
Houston Texas, 77030, United States
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