Trial | NCT00609401  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
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.
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.
Study Started
Nov 30
2006
Primary Completion
May 31
2007
Study Completion
May 31
2008
Last Update
Feb 26
2009
Estimate

Drug Nexavar (Sorafenib)

400 mg bid

Drug IL-2

IL-2 3 MU per 5 day/week for 2 weeks every 4

1 Experimental

Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4

2 Experimental

Sorafenib 400 mg bid

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
No Results Posted