Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

Inclusion Criteria:

• No prior sorafenib

• Histologically or cytologically confirmed uterine carcinoma or carcinosarcoma:

  • Advanced or recurrent disease
  • Not amenable to curative surgery or radiotherapy

• Measurable disease:

  • At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
• Tumor tissue block must be available
• No known brain metastases

• Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

• Hematopoietic:

  • Absolute neutrophil count >= 1,500/mm3
  • Platelet count >= 100,000/mm3
  • No bleeding diathesis

• Hepatic:

  • Bilirubin normal
  • AST and ALT =< 2.5 times upper limit of normal

• Renal:

  • Creatinine =< 1.5 mg/dL OR
  • Creatinine clearance >= 60 mL/min

• Cardiovascular:

  • No uncontrolled hypertension, defined by 1 of the following:

    • Blood pressure > 150/100 mm Hg
    • Currently taking > 1 antihypertensive agent
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other active malignancy
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No swallowing dysfunction that would preclude study drug ingestion
• No other uncontrolled illness
• Prior biological response modifier therapy allowed
• No prior antiangiogenesis therapy
• No prior MAPK-signaling agents
• No prior vascular endothelial growth factor receptor (VEGFR) inhibitors
• No more than 1 prior chemotherapy regimen
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• Prior hormonal therapy allowed
• Prior radiotherapy allowed provided the only site of measurable disease was not located within the radiation port OR disease has progressed since completion of therapy
• Recovered from all prior therapy

• Concurrent warfarin allowed provided all of the following are true:

  • Patient is therapeutic on a stable warfarin dose
  • INR target range =< 3
  • Patient is monitored with weekly INR testing
  • No active bleeding or pathological condition that carries a high bleeding risk
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
• No concurrent rifampin
• No concurrent Hypericum perforatum (St. John's wort)
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• More than 4 weeks since prior radiotherapy