Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The ROSORC trial is a randomized study comparing the efficacy of a new association (sorafenib and IL-2) versus the standard therapy (sorafenib) in patients affected by different histotypes of metastatic RCC. This study is a first line therapy for the advanced disease. The primary objective is the progression free survival (PFS) in the 2 arms of therapy and the secondary objective is the overall survival (OS) and the response rate (RR) and the safety profile of the combination compared to sorafenib alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italian Trial in Medical Oncology
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Cytohistological diagnosis of RCC

• Written informed consent

• Measurable disease according to RECIST criteria

• Age >= 18 years

• Karnofsky PS >= 60%

• Life expectancy of greater than 3 months

Exclusion Criteria:

• Prior medical treatment for metastatic RCC

• Brain metastasis or spinal cord compression

• Chronic treatment with corticosteroids

• Uncontrolled hypertension