Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
Condition: 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
MeSH terms: Carcinoma; Adenocarcinoma; Cystadenocarcinoma, Serous; Brenner Tumor; Recurrence
Intervention: Laboratory Biomarker Analysis; Pharmacological Study; Selumetinib; Selumetinib Sulfate
Intervention description: Correlative studies; Correlative studies; Given PO; Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No

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.
    

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