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

Renal Cell Carcinoma Clinical Trial

— ROSORC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609401
• Other study ID #: EudraCT number 2006-003137-32
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2008
• Last updated: February 25, 2009
• Start date: November 2006
• Est. completion date: May 2008

Study information

• Verified date: February 2009
• Source: Italian Trial in Medical Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Disease
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Renal Cell Carcinoma

Intervention

Drug:
• Nexavar (Sorafenib)
400 mg bid
• IL-2
IL-2 3 MU per 5 day/week for 2 weeks every 4

Locations

Country	Name	City	State
Italy	Istituto Tumori	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Italian Trial in Medical Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		2 years	Yes

External Links

•   Link