Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: Sunitinib
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sutent; sunitinib

Summary:

      The purpose of this study is to determine the effectiveness of sunitinib on participants with
      ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may
      stop cancer cells from growing by blocking the blood supply to the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed epithelial ovarian, fallopian tube or
             peritoneal cancer

          -  Recurrent or refractory disease

          -  Measurable disease, defined by RECIST

          -  0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease

          -  Adverse events related to prior tumor-specific therapy must have resolved to less than
             or equal to grade 1 prior to study entry

          -  Ability to swallow oral medications

          -  18 years of age or older

          -  ECOG Performance status must be 0-2

          -  Normal organ and marrow function as outlined in the protocol

        Exclusion Criteria:

          -  Receiving systemic therapy less than 14 days prior to starting sunitinib

          -  Receiving any other investigational agent

          -  Received prior sunitinib

          -  Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain
             metastases or leptomeningeal disease as noted on screening CT or MRI scans

          -  Any of the following within the 6 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, or pulmonary embolism.

          -  Evidence of a bleeding diathesis. Major surgery or NCI CTCA 3.0 grade 3 or worse
             hemorrhage within 4 weeks of starting study treatment

          -  Ongoing cardiac dysrhythmias of NCI CTCAE version 3.0 grade > 2

          -  Pre-existing thyroid abnormality, with thyroid function tests that cannot be
             maintained in the normal range with medication

          -  Prolonged QTc interval on baseline EKG

          -  Uncontrolled hypertension

          -  Patients who are taking cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin,
             theophylline, ketoconazole, or St. John's wort.

          -  Psychiatric illness or social situations that wold limit compliance with study
             requirements

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration

          -  Pregnant women

          -  Clinical or radiographical evidence of a small bowel obstruction

          -  Poor oral intake