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Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial

Phase 3
19 Years
75 Years
Not Enrolling
Renal Cell Cancer

Thank you

Trial Information

Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial

Treatment plan Group A

Patients randomised to group A will receive treatment according to the following treatment

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;


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

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

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

Inclusion Criteria:

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

- 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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary study objective is to investigate whether the addition of capecitabine to interferon-alpha-interleukin-2 based immunotherapy may improve progression free survival when compared to immunotherapy alone.

Principal Investigator

Manuela Schmidinger, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univ. Klinik f. Innere Med. I, Abt. Onkologie


Austria: Federal Ministry for Health and Women

Study ID:

CECOG RCC 1.3.001



Start Date:

March 2004

Completion Date:

May 2007

Related Keywords:

  • Renal Cell Cancer
  • renal cell cancer
  • Carcinoma
  • Carcinoma, Renal Cell