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

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 peritonealcarcinoma that recur as low grade serous carcinoma (invasive micropapillaryserous carcinoma or invasive grade I serous carcinomas as defined by GynecologicOncology Group [GOG], International Federation of Gynecology and Obstetrics [FIGO] World Health Organization [WHO] or Silverberg)
• Patients initially diagnosed with serous borderline ovarian or peritonealcarcinoma that recur as low grade serous carcinoma (invasive micropapillaryserous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGOWHO or Silverberg)
• Patients must have measurable disease:
• Measurable disease is defined as at least one lesion that can be accuratelymeasured 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 magneticresonance imaging (MRI), or >= 10 mm when measured by spiral CT
• Patient must have documented low grade serous carcinoma (invasive micropapillaryserous); confirmation must occur before patient is considered eligible for the trial
• Patients whose primary tumor was low-grade serous ovarian or peritoneal carcinomamust have a pretreatment sample of their tumor from their primary or recurrenttumor that documents low grade serous carcinoma (invasive micropapillary serous)
• Patients whose primary tumor was serous borderline ovarian or peritonealcarcinoma must have a pretreatment sample of their tumor from their recurrenttumor 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 agreeto practice an effective means of birth control prior to study entry, for the durationof 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 permittingrelease 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 fornitrosoureas or mitomycin C) prior to entering the study or those who have notrecovered 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 trialbecause of their poor prognosis and because they often develop progressive neurologicdysfunction that would confound the evaluation of neurologic and other adverse events
• History of allergic reactions attributed to compounds of similar chemical or biologiccomposition 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 increasethe risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia,family history of long QT interval syndrome) including heart failure that meets NewYork 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 affectselected CYP450 isoenzymes
• Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatorybowel disease), or significant bowel resection that would preclude adequate absorption
• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection or psychiatric illness/social situations that would limit compliance withstudy requirements
• Pregnant women are excluded from this study because the effects of AZD6244 on thedeveloping human fetus at the recommended therapeutic dose are unknown; because thereis an unknown but potential risk for adverse events in nursing infants secondary totreatment of the mother, breastfeeding should be discontinued if the mother is treatedwith AZD6244
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviraltherapy are ineligible because of the potential for pharmacokinetic interactions withAZD6244; appropriate studies will be undertaken in patients receiving combinationantiretroviral therapy when indicated