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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00551070

Run by

National Cancer Institute (NCI)

People needed

52

Starts

2007-12-17

Expected to finish

2020-11-13

Last updated by the study team

2020-12-03

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Hinsdale Hematology Oncology Associates Incorporated — Hinsdale, Illinois, United States
• Saint Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• Maine Medical Center-Bramhall Campus — Portland, Maine, United States
• Christiana Care - Union Hospital — Elkton, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Bronson Battle Creek — Battle Creek, Michigan, United States
• Spectrum Health Big Rapids Hospital — Big Rapids, Michigan, United States
• Cancer Research Consortium of West Michigan NCORP — Grand Rapids, Michigan, United States
• Mercy Health Saint Mary's — Grand Rapids, Michigan, United States
• Spectrum Health at Butterworth Campus — Grand Rapids, Michigan, United States
• Holland Community Hospital — Holland, Michigan, United States
• Mercy Health Partners-Hackley Campus — Muskegon, Michigan, United States
• Mercy Health Mercy Campus — Muskegon, Michigan, United States
• Munson Medical Center — Traverse City, Michigan, United States
• Metro Health Hospital — Wyoming, Michigan, United States

Full record on ClinicalTrials.gov

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