NCT00311467

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Renal Cell Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-03-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-04-06
• Last updated: 2012-05-16

Locations

1 site across 1 country: Austria