Status:
TERMINATED
Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma
Lead Sponsor:
Central European Cooperative Oncology Group
Conditions:
Renal Cell Cancer
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief 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 metas...
Detailed Description
Treatment plan Group A Patients randomised to group A will receive treatment according to the following treatment schedule: Group A: Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy *...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00311467
Start Date
March 1 2004
End Date
May 1 2007
Last Update
May 16 2012
Active Locations (1)
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1
Univ. Klinik f. Innere Medizin, Abt. Onkologie
Vienna, Austria, 1090