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

Renal Cell Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer

• NCT number: NCT00311467
• Study type: Interventional
• Source: Central European Cooperative Oncology Group
• Status: Terminated
• Phase: Phase 3
• Start date: March 2004
• Completion date: May 2007