Clinical trial NCT00732914 (phase 3, status: completed)
Conditions: renal cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: sunitinib (sutent), sorafenib (nexavar)
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Patients with metastatic / advanced RCC (all histologies), who are not suitable for
             cytokine therapy and for whom study medication constitutes first-line therapy

          2. Age >= 18 ans <= 85years

          3. ECOG Performance Status of 0 or 1

          4. MSKCC prognostic score, low or intermediate

          5. Life expectancy of at least 12 weeks.

          6. Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions
             must be measured by CT/MRI-scan.

          7. Adequate bone marrow, liver and renal function as assessed by the following laboratory
             requirements to be conducted within 7 days prior to start of therapy:

               -  Hemoglobin >= 9.0 g/dl

               -  Absolute neutrophil count (ANC) >= 1,500/mm³

               -  Platelet count >= 100,000/μl

               -  Total bilirubin <= 1.5 times the upper limit of normal

               -  ALT and AST <= 2.5 x upper limit of normal (<= 5 x upper limit of normal for
                  patients with liver involvement of their cancer)

               -  Alkaline phosphatase < 4 x upper limit of normal

               -  PT-INR/PT < 1.5 x upper limit of normal [Patients who are being therapeutically
                  anticoagulated with an agent such as coumadin or heparin will be allowed to
                  participate provided that no prior evidence of underlying abnormality in these
                  parameters exists.]

               -  Serum creatinine <= 2 x upper limit of normal.

          8. Written Informed Consent

        Exclusion Criteria:

          1. History of cardiac disease: congestive heart failure >NYHA class 2 or with LVEF at
             baseline echocardiography < 50%; active CAD (MI more than 6 months prior to study
             entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta
             blockers or digoxin are permitted) or uncontrolled hypertension (defined as blood
             pressure >= 160 mmHg systolic and/or >= 90 mmHG diastolic on medication).

          2. History of HIV infection or chronic hepatitis B or C

          3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)

          4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months
             from definitive therapy, has a negative imaging study within 4 weeks of study entry
             and is clinically stable with respect to the tumor at the time of study entry)

          5. Patients with seizure disorder requiring medication (such as steroids or
             anti-epileptics)

          6. History of organ allograft

          7. Patients with evidence or history of bleeding diathesis

          8. untreated hypothyrosis

          9. Patients undergoing renal dialysis

         10. Previous or concurrent cancer that is distinct in primary site or histology from the
             cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
             cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively
             treated > 3 years prior to study entry.

         11. Pregnant or breast-feeding patients. Women of childbearing potential must have a
             negative pregnancy test performed within 7 days of the start of treatment. Both men
             and women enrolled in this trial must use adequate barrier birth control measures
             during the course of the trial and 3 months after the completion of trial.

         12. Substance abuse, medical, psychological or social conditions that may interfere with
             the patient's participation in the study or evaluation of the study results

         13. Any condition that is unstable or could jeopardize the safety of the patient and their
             compliance in the study

         14. Patients unable to swallow oral medications

         15. Known allergy to sunitinib or sorafenib or one of its constituents

        Excluded therapies and medications, previous and concomitant:

          1. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study
             entry.

          2. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative
             radiotherapy will be allowed). Major surgery within 4 weeks of start of study

          3. Autologous bone marrow transplant or stem cell rescue within 4 months of study

          4. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry.

             [G-CSF and other hematopoietic growth factors may be used in the management of acute
             toxicity such as febrile neutropenia when clinically indicated or at the discretion of
             the investigator; however they may not be substituted for a required dose reduction.]
             [Patients taking chronic erythropoietin are permitted provided no dose adjustment is
             undertaken within 2 months prior to the study or during the study]

          5. Investigational drug therapy outside of this trial during or within 4 weeks of study
             entry

          6. Prior exposure to the study drug.

          7. Any St. John's wort containing remedy