Sunitinib in Treating Patients With Advanced or Metastatic Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

  • Ovarian epithelial cancer
  • Fallopian tube cancer
  • Primary peritoneal cancer
• Advanced and/or metastatic disease incurable by standard therapies
• Must have received at least 1 but no more than 2 prior chemotherapy regimens* (1 must have been platinum-containing) AND may be either platinum-sensitive or platinum-resistant NOTE: *Switching from 1 platinum compound to another for reasons of disease progression or failure to respond is considered a second regimen; the same regimen given as first- and second-line therapy is also considered 2 regimens

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan OR ≥ 10 mm by spiral CT scan

  • Patients with CA125 as only evidence of disease are not eligible
  • Measurable disease must be outside of a previously irradiated area
  • Sole site of disease in a previously irradiated area is not allowed unless there is evidence of disease progression or new lesions were documented in the irradiated field
• No known brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy ≥ 12 weeks
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Calcium ≤ 3 mmol/L
• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other curatively treated solid tumors
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
• No QTc prolongation, defined as QTc interval ≥ 500 msec, or other significant ECG abnormalities

• No New York Heart Association (NYHA) class III-IV heart failure

  • History of NYHA class II heart failure allowed provided both of the following criteria are met:

    • Asymptomatic with respect to cardiac function
    • LVEF > lower limit of normal as assessed by MUGA at baseline
• No poorly controlled hypertension (systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
• No myocardial infarction, cardiac arrhythmia, stable or unstable angina, or symptomatic congestive heart failure within the past year
• No pulmonary embolism within the past year
• No cerebrovascular accident or transient ischemic attack within the past year
• No bowel obstruction or any other condition (e.g., gastrointestinal [GI] tract disease resulting in an inability to take oral medication, requirement for IV alimentation, or active peptic ulcer disease) that would impair ability to swallow and retain sunitinib malate tablets

• No serious illness or medical condition, including, but not limited to, any of the following:

  • History of significant neurologic or psychiatric disorder that would preclude study compliance
  • Active uncontrolled infection
  • Other medical conditions that would be aggravated by treatment
  • Serious or nonhealing wound, ulcer, or bone fracture
  • Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28 days
• No preexisting hypothyroidism unless euthyroid on medication
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No more than 1 prior hormonal treatment for metastatic disease
• No prior surgical procedures affecting absorption
• No prior antiangiogenic agents or multitargeted tyrosine kinase inhibitors (e.g., bevacizumab, sorafenib, pazopanib, thalidomide, ZD6474, AMG 706, AZD2171, vatalanib, or VEGF Trap)

• No prior anthracycline exposure or thoracic radiotherapy that included the heart in the radiotherapy port, unless all of the following criteria are met:

  • Asymptomatic with respect to cardiac function
  • LVEF > lower limit of normal as assessed by MUGA at baseline
• At least 1 year since prior coronary/peripheral artery bypass graft or stenting
• At least 28 days since prior hormonal therapy
• At least 28 days since prior chemotherapy and recovered

• At least 28 days since prior radiotherapy and recovered

  • Radiotherapy must have involved < 30% of functioning bone marrow
• At least 28 days since prior major surgery and recovered

• At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:

  • Azole antifungals (e.g., ketoconazole, itraconazole, or miconazole)
  • Erythromycin
  • Diltiazem
  • Verapamil
  • HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)
  • Delavirdine
  • Clarithromycin

• At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:

  • Rifampin
  • Rifabutin
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Hypericum perforatum (St. John's wort)
  • Efavirenz
  • Tipranavir

• No concurrent agents with proarrhythmic potential, including any of the following:

  • Terfenadine
  • Quinidine
  • Procainamide
  • Disopyramide
  • Sotalol
  • Probucol
  • Bepridil
  • Haloperidol
  • Risperidone
  • Indapamide
  • Flecainide

• No concurrent therapeutic coumarin-derivative anticoagulants (e.g., warfarin)

  • Warfarin (≤ 2 mg/day) allowed for prophylaxis of thrombosis
  • Concurrent low molecular weight heparin allowed provided INR ≤ 1.5
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer therapy or other investigational agents