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

This study has been terminated.
(no patient recruitment)
Sponsor:
Information provided by (Responsible Party):
Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00311467
First received: April 5, 2006
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Renal Cell Cancer
Drug: Capecitabine, Interferon, Interleukin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial

Resource links provided by NLM:


Further study details as provided by Central European Cooperative Oncology Group:

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

Enrollment: 172
Study Start Date: March 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Capecitabine and Interferon
Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy
Drug: Capecitabine, Interferon, 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 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

Active Comparator: Interferon

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

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


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

  • 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

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311467

Locations
Austria
Univ. Klinik f. Innere Medizin, Abt. Onkologie
Vienna, Austria, 1090
Sponsors and Collaborators
Central European Cooperative Oncology Group
Investigators
Principal Investigator: Manuela Schmidinger, Prof Univ. Klinik f. Innere Med. I, Abt. Onkologie
  More Information

Additional Information:
No publications provided

Responsible Party: Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00311467     History of Changes
Other Study ID Numbers: CECOG RCC 1.3.001
Study First Received: April 5, 2006
Last Updated: May 15, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Central European Cooperative Oncology Group:
renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Capecitabine
Fluorouracil
Interferons
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014