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

Central European Cooperative Oncology Group

Status and phase: Terminated; Phase 3

Conditions: Renal Cell Cancer

Treatments: Drug: Capecitabine, Interferon, Interleukin

Study type: Interventional

Funder types: Other

Identifiers

NCT00311467

CECOG RCC 1.3.001

Details and patient eligibility

About

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.

Full 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

• Week 1:Capecitabine / Interferon;
• Week 2:Capecitabine / Interferon;
• Week 3:REST PERIOD / Interleukin;
• Week 4:Capecitabine / Interleukin;
• Week 5:Capecitabine / REST PERIOD;
• Week 6:REST PERIOD / Interferon;
• Week 7:Capecitabine / Interferon;
• Week 8:Capecitabine / Interleukin;
• Week 9:REST PERIOD / Interleukin;
• Week 10:Capecitabine / REST PERIOD;
• Week 11:Capecitabine / Interferon;
• Week 12:REST PERIOD / Interferon;
• Week 13:Capecitabine / Interleukin;
• Week 14:Capecitabine / Interleukin;

DOSAGES AND ROUTES OF ADMINISTRATION:

Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.

Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.

Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.

Group B

Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.

Efficacy evaluations will be performed every 14 weeks of treatment in both groups

Enrollment: 172 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Capecitabine and Interferon

Active Comparator group

Description:

Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy

Treatment:

Drug: Capecitabine, Interferon, Interleukin

Interferon

Active Comparator group

Description:

Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine. Efficacy evaluations will be performed every 14 weeks of treatment in both groups

Treatment:

Drug: Capecitabine, Interferon, Interleukin