Clinical trial NCT00496756 (phase 2, status: terminated)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: sorafenib
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    low accrual rate.
  
Eligibility criteria:

        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