Trial Search Results

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

This phase II trial is studying the side effects and how well selumetinib works in treating patients with recurrent low-grade ovarian cancer. Selumetinib 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)

Stanford Investigator(s):

Intervention(s):

  • Drug: selumetinib
  • Other: pharmacological study
  • Other: laboratory biomarker analysis

Phase:

Phase 2

Eligibility


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

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