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

Italian Trial in Medical Oncology

Status and phase: Completed; Phase 2

Conditions: Metastatic Disease; Renal Cell Carcinoma

Treatments: Drug: IL-2; Drug: Nexavar (Sorafenib)

Study type: Interventional

Funder types: Other

Identifiers

NCT00609401

EudraCT number 2006-003137-32

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: IL-2

Drug: Nexavar (Sorafenib)

2

Experimental group

Description:

Sorafenib 400 mg bid

Treatment:

Drug: Nexavar (Sorafenib)