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

Inclusion Criteria:

• Meeting 1 of the following diagnosis:

  • Low-grade ovarian carcinoma that recurred as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO, or S. G. Silverberg) or peritoneal carcinoma
  • Serous borderline ovarian carcinoma that recurred as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO, or S. G. Silverberg) or peritoneal carcinoma
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques including palpation, plain x-ray, CT scan, or MRI scan, OR ≥ 10 mm by spiral CT scan
• Patients whose primary tumor was serous borderline ovarian carcinoma, low-grade serous ovarian carcinoma, 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)
• No known brain metastases
• GOG performance status 0-1
• Platelet count ≥ 100,000/mm³
• ANC count ≥ 1,500/mm³
• Bilirubin < 1.5 times upper limit of normal (ULN)
• Creatinine < 1.5 times ULN
• Transaminases < 2.5 times ULN
• Neuropathy ≤ grade 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception prior to, during, and for 4 weeks after completion of study therapy

• QTc interval ≤ 450 msec and no factors that increase the risk of QT prolongation or arrhythmic events including, but not limited to, any of the following:

  • Heart failure
  • Hypokalemia
  • Family history of long QT interval syndrome
  • NYHA class III-IV heart failure
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD6244 or its excipient Captisol
• No refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
• No uncontrolled intercurrent illness including ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements
• More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• No prior AZD6244
• No prior MEK inhibitor
• No HIV-positive patients on combination antiretroviral therapy
• No concurrent medications with the potential to prolong the QT interval
• No concurrent drugs known to affect or with the potential to affect selected CYP450 isoenzymes
• No concurrent grapefruit or grapefruit juice during AZD6244 administration
• No other concurrent investigational or commercial agents for this cancer