Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central European Cooperative Oncology Group
• Treatments: Capecitabine; Interferons

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