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

NCT00311467 | Terminated Phase 3

• 1 other identifier: CECOG RCC 1.3.001
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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 metastatic renal cell carcinoma.

Conditions

Renal Cell Cancer

Keywords

renal cell cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• The study's secondary objectives are to investigate differences in response rates, safety and survival.

Study Arms (2)

Capecitabine and Interferon

ACTIVE COMPARATOR

Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy

Drug: Capecitabine, Interferon, Interleukin

Interferon

ACTIVE COMPARATOR

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

Drug: Capecitabine, Interferon, Interleukin

Interventions

Capecitabine, Interferon, Interleukin DRUG

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

Capecitabine and Interferon; Interferon

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central European Cooperative Oncology Group: lead

Study Sites (1)

Univ. Klinik f. Innere Medizin, Abt. Onkologie

Vienna, 1090, Austria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Capecitabine; Interferons; Interleukins

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Manuela Schmidinger, Prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Study Start: March 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

AU (1)