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

May 15, 2012 updated by: Central European Cooperative Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Univ. Klinik f. Innere Medizin, Abt. Onkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central European Cooperative Oncology Group

Investigators

  • Principal Investigator: Manuela Schmidinger, Prof, Univ. Klinik f. Innere Med. I, Abt. Onkologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECOG RCC 1.3.001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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