Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Collaborator: NRG Oncology

Stanford Investigator(s):

Intervention(s):

  • Other: Laboratory Biomarker Analysis
  • Other: Pharmacological Study
  • Drug: Selumetinib
  • Drug: Selumetinib Sulfate

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

19 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting