Clinical trial NCT00311467 (phase 3, status: terminated)
Conditions: renal cell cancer
ICD codes: C96.20, C96.29, D47.09
Drugs: capecitabine, interferon, interleukin
SMILES: CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O
Reason stopped: 
    no patient recruitment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed renal cell carcinoma (primary tumour or biopsy/surgery of
             metastases)

          -  Radiologically confirmed metastatic disease

          -  Surgically removed primary tumour so feasible (nephrectomy or nephron-sparing surgery
             as indicated)

          -  Karnofsky-Performance Status >70%

          -  Age 19-75 years

          -  Life expectancy of at least 3 months

          -  Adequate bone marrow function (i.e. white blood cell count above 3000/μL, platelet
             count above 75 000 /μL, hemoglobin above 9 mg/dl)

          -  Adequate organ function (i.e. serum creatinine, bilirubin and AST below 1.25 x the
             upper limit of the institutions' normal range)

          -  Negative pregnancy test for female patients

          -  Written informed consent

        Exclusion Criteria:

          -  Age <19 or >75 years

          -  Karnofsky-Performance Status < 70%

          -  Untreated or uncontrolled brain metastases

          -  Second neoplasia

          -  Primary tumour surgically removable

          -  Solitary, surgically removable metastases

          -  Major concomitant diseases of the cardiovascular, respiratory or renal systems, as
             well as active systemic infections

          -  Severe renal disease or liver insufficiency or myeloid dysfunction (including patients
             with a history of a disease that is likely to interfere with the metabolism or
             excretion of the test medication)

          -  Other less common diseases as peptic ulcer disease, inflammatory bowel disease,
             autoimmune disease (severe known psoriasis, idiopathic thrombocytopenic purpura, lupus
             erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)

          -  Drug addiction (including excessive alcohol consumption) within 1 year prior to study
             start.

          -  History of other conditions consistent with decompensated liver disease or other
             evidence of bleeding form esophageal varices.

          -  History of chronic hepatitis and immunsupressiva

          -  Known HIV Infection

          -  Evidence of allergy or hypersensitivity against recombinant Interferon alfa-2a or
             other components of preparation.

          -  History of severe psychiatric disease, especially depression. Severe psychiatric
             disease is defined as treatment with an antidepressant medication or a major
             tranquilizer at therapeutic doses for major depression or psychosis, respectively, for
             at least 3 months at any previous time or any history of the following: a suicidal
             attempt, hospitalization for psychiatric disease, or a period of disability due to a
             psychiatric disease.

          -  Seizure disorders and /or compromised central nervous system function.

          -  History of evidence of severe retinopathy

          -  Patient unwilling or unable to give informed consent

          -  Pregnancy or breastfeeding