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

Primary Purpose

Metastatic Disease, Renal Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Nexavar (Sorafenib)

IL-2

About this trial

This is an interventional treatment trial for Metastatic Disease focused on measuring Sorafenib, RCC, Metastatic disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Istituto Tumori

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

Sorafenib 400 mg bid

Outcomes

Primary Outcome Measures

PFS

Secondary Outcome Measures

Full Information

NCT ID

NCT00609401

First Posted

January 11, 2008

Last Updated

February 25, 2009

Sponsor

Italian Trial in Medical Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00609401

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Italian Trial in Medical Oncology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Disease, Renal Cell Carcinoma

Keywords

Sorafenib, RCC, Metastatic disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

Sorafenib 400 mg bid

Intervention Type

Drug

Intervention Name(s)

Nexavar (Sorafenib)

Intervention Description

400 mg bid

Intervention Type

Drug

Intervention Name(s)

IL-2

Intervention Description

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

Primary Outcome Measure Information:

Title

PFS

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: