Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer

This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer Read More

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed renal cell carcinoma (RCC)

  • Must have a component of conventional clear cell RCC

    • Predominant clear cell component ≥ 75%
  • Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors, or transitional cell carcinoma are not eligible
• Metastatic or unresectable disease

• Measurable or nonmeasurable disease

  • Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or MRI

  • Nonmeasurable disease includes any of the following:

    • Small lesions with longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan
    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Lymphangitis cutis/pulmonitis
    • Abdominal masses that are not confirmed and followed by imaging techniques
    • Cystic lesions
    • Irradiated lesions, unless progression is documented after radiotherapy
• Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry staining of VEGF

• No evidence of CNS metastases

  • No imaging (MRI or CT scan of the brain) abnormality indicative of CNS metastases within the past 42 days

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception (hormonal and/or barrier method) during and for 3 months after completion of study treatment
• Granulocyte count ≥ 1,500/µL
• Platelet count ≥ 100,000/µL
• AST/ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Serum bilirubin ≤ 1.5 times ULN
• Protein ≤ 1+ by urinalysis
• Creatinine ≤ 1.5 times ULN
• No ongoing hemoptysis
• No cerebrovascular accident within the past 12 months
• No peripheral vascular disease with claudication while walking less than 1 block
• No history of clinically significant bleeding
• No deep venous thrombosis or pulmonary embolus within the past year
• No significant cardiovascular disease, defined as NYHA class II-IV congestive heart failure, angina pectoris requiring nitrate therapy, or myocardial infarction within the past 6 months
• No uncontrolled hypertension, defined as systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg while on medication
• No preexisting thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication
• No uncontrolled psychiatric disorder
• No delayed healing of wounds, ulcers, and/or bone fractures

• No currently active second malignancy except nonmelanoma skin cancer

  • Patients are not considered to have a 'currently active' malignancy if they have completed anticancer therapy and are considered by their physician to be at less than 30% risk of relapse

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior major surgery and/or radiotherapy and recovered
• No more than one prior systemic therapy for RCC
• No prior vascular endothelial growth factor receptor agents
• Prior palliative radiotherapy for metastatic lesion(s) allowed provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
• More than 4 weeks since prior and no other concurrent anticancer therapy
• Concurrent continuation of bisphosphonates allowed for bone metastases prophylaxis

• No concurrent systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency)

  • Topical and/or inhaled steroids allowed

• No concurrent full-dose oral or parenteral anticoagulation

  • Low-dose warfarin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin allowed
• No concurrent Hypericum perforatum (St. John's wort)
• No concurrent ketoconazole, itraconazole, ritonavir, rifampin, or products containing grapefruit juice

• No concurrent hormonal therapy or chemotherapy

  • Concurrent hormones administered for non-disease related conditions (e.g., insulin for diabetes) allowed