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

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients will be allocated in 2 groups: ARM A - Sorafenib 400 mg twice daily continuously and low dose of IL-2 administered s.c. ARM B - Sorafenib alone at the same dosage used in the previous arm The trial is stratified according to the MSKCC prognostic model (low intermediate high risk) and histology (Clear cell vs other histotypes). The main inclusion criteria are: cytohistological diagnosis of RCC, measurable disease as RECIST criteria, signed written informed consent, life expectancy of greater than 3 months. The efficacy and safety analysis will be performed on an intent to treat population. The anticipated median PFS time in the control arm is 6 months and we will expect an increase of 3 months in the experimental arm. The sample size is 128 patients, 64 in each arm (1:1 randomization) The study started in November 2006 and is a multicenter Italian trial.

Official Title
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A Randomized Open Label Multicenter Phase II Study of First Line Therapy With Sorafenib in Association With IL-2 vs Sorafenib Alone in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

Conditions
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Metastatic Disease, Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Nexavar (Sorafenib)
* Drug: IL-2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4 | Drug: Nexavar (Sorafenib)<br>* 400 mg bid<br>Drug: IL-2<br>* IL-2 3 MU per 5 day/week for 2 weeks every 4<br>|
| Experimental: 2<br>Sorafenib 400 mg bid | Drug: Nexavar (Sorafenib)<br>* 400 mg bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sorafenib, RCC, Metastatic disease