Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission

DISEASE CHARACTERISTICS:

• Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum

  • Any stage and grade at diagnosis

• Must have received initial cytoreductive surgery and chemotherapy with ≥ 1 platinum-based chemotherapy regimen

  • Persistent or recurrent disease after initial therapy

• In complete clinical remission after chemotherapy for recurrent disease, meeting all of the following criteria:

  • CA125 ≤ 35 units/L
  • Normal physical examination

  • No definite evidence of disease by CT scan of the abdomen and pelvis

    • Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm are not considered definite evidence of disease
• No known brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Karnofsky performance status 70-100%
• Life expectancy > 3 months
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• INR < 1.5 OR PT/PTT within normal limits
• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Urinalysis negative for protein

  • If urinalysis shows 1+ protein by dipstick or protein ≥ 30-100 mg/dL by semi-quantitative assay, a 24-hour urine collection is required

    • Eligible patients must have a total urinary protein ≤ 500 mg AND measured creatinine clearance ≥ 50 mL/min from a 24-hour urine collection
• Bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Stable blood pressure (BP) measurement required on 3 separate days prior to the start of treatment
• No peripheral neuropathy > grade 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Exclusion criteria:

• Other invasive malignancies within the past 5 years, except nonmelanoma skin cancer

• Uncontrolled concurrent illness or medical condition including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Uncontrolled diabetes
• Psychiatric illness or social situation that would preclude study compliance
• Uncontrolled hypertension defined as a persistent BP > 150/100 mm Hg (or a persistent BP > 180/90 mm Hg if the patient has a history of isolated systolic hypertension) despite ≥ 2 attempts at antihypertensive medication dosage adjustment ≥ 2 weeks apart
• Thrombolic or embolic events such as cerebrovascular accident, including transient ischemic attack, within the past 6 months
• Pulmonary hemorrhage or bleeding event ≥ grade 2 within 4 weeks of the first dose of study drug
• Other hemorrhage or bleeding event ≥ grade 3 within 4 weeks of the first dose of study drug
• Serious nonhealing wound, ulcer, or bone fracture
• Evidence or history of bleeding diathesis or coagulopathy
• Inability to take oral medications or gastrointestinal condition that compromises absorption
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib tosylate

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics
• No prior sorafenib tosylate or other inhibitors of MAPK signaling intermediates or angiogenesis inhibitors
• No prior cancer treatment that would contraindicate protocol therapy
• More than 4 weeks since prior radiotherapy
• More than 3 weeks since prior chemotherapy, biological therapy, or immunotherapy
• More than 1 week since prior hormonal therapy for cancer treatment

Exclusion criteria:

• Major surgery (i.e., laparotomy) within the past 4 weeks or minor surgery within the past 2 weeks

  • Placement of a vascular access device is not considered minor surgery
• Concurrent combination antiretroviral therapy for HIV-positive patients
• Concurrent St. John wort, rifampin, or enzyme-inducing anticonvulsants (e.g., carbamazepine, phenytoin, or phenobarbital)