Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: Sorafenib
Intervention description: initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: clear cell renal cell carcinoma; stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer

Summary:

      RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in
      treating patients with metastatic or unresectable kidney cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed renal cell carcinoma (RCC)

               -  Must have a component of conventional clear cell RCC

               -  Predominant clear cell component ≥ 75%

          -  Metastatic or unresectable 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)

          -  Measurable or nonmeasurable disease, includes any of the following:

               -  Small lesions, 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

          -  Karnofsky performance status 70-100%

          -  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

          -  At least 4 weeks since prior major surgery and/or radiotherapy and recovered

          -  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

        Exclusion Criteria:

          -  Patients with true papillary, sarcomatoid features without any clear cell component,
             chromophobe, oncocytoma, collecting duct tumors, or transitional cell carcinoma are
             not eligible

          -  No evidence of CNS metastases

          -  No imaging (MRI or CT scan of the brain) abnormality indicative of CNS metastases
             within past 42 days

          -  Not pregnant or nursing (negative pregnancy test)

          -  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)

          -  No more than one prior systemic therapy for RCC

          -  No prior vascular endothelial growth factor receptor agents

          -  No concurrent systemic corticosteroid therapy (except replacement therapy for adrenal
             insufficiency)

             o Topical and/or inhaled steroids allowed

          -  No concurrent full-dose oral or parenteral anticoagulation

             o 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 o Concurrent hormones administered for
             non-disease related conditions (e.g., insulin for diabetes) allowed