Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib

Exclusion Criteria

• •1. Predominant clear-cell RCC
• •2. Resectability or other curative options
• •3. Any investigational drug within the 30 days before inclusion.
• •4. Prior systemic treatment for their RCC.
• •5. Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
• •6. Radiotherapy within the last 4 weeks.
• •7. Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
• •8. Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
• •9. Clinically symptomatic brain or meningeal metastasis. (known or suspected)
• •10. Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
• •11. History of any of the following cardiac events within the past 6 months:
• •* myocardial infarction (including severe/unstable angina),
• •* coronary/peripheral artery bypass graft,
• •* congestive heart failure (CHF),
• •* cerebrovascular accident,
• •* transient ischemic attack,
• •* pulmonary embolism.
• •12. No hemorrhage ≥ grade 3 within the past 4 weeks
• •13. Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ≥3 anti-hypertensive drugs
• •14. History of relevant pulmonary hypertension or interstitial lung disease.
• •15. Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
• •16. Previous malignancy (other than renal cancer cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor \[Ta, Tis and T1\].
• •17. History of organ allograft
• •18. Significant disease which, in the investigator's opinion would exclude the patient from the study
• •19. Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital)
• •20. Patients under strong inducers or inhibitors to CYP Isoenzymes
• •21. Patients with hypersensitivity to the antihistamine or patients who cannot receive the antihistamine for other medical reasons
• •22. Patients requiring long-term cortisone therapy
• •23. Patients requiring oral anticoagulation treatment, such as marcoumar. (Anticoagulation treatment with heparin or low molecular weight heparin \[LMWH\] is allowed provided that close monitoring is performed).
• •24. Surgery within at least 2 weeks prior to randomization
• •25. HIV seropositivity.
• •26. Abnormal pulmonary function (DLCO \< 50%). \[Pulmonary function tests need only to be performed if abnormal pulmonary function present in medical history\].
• •27. Poorly controlled diabetes mellitus.
• •28. Liver cirrhosis, chronic hepatitis
• •29. Legal incapacity or limited legal capacity
• •30. Known alcohol or drug abuse.
• •31. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.