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

This study has been completed.
Sponsor:
Information provided by:
Italian Trial in Medical Oncology
ClinicalTrials.gov Identifier:
NCT00609401
First received: January 11, 2008
Last updated: February 25, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Metastatic Disease
Renal Cell Carcinoma
Drug: Nexavar (Sorafenib)
Drug: IL-2
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Italian Trial in Medical Oncology:

Primary Outcome Measures:
  • PFS [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: November 2006
Study Completion Date: May 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4
Drug: Nexavar (Sorafenib)
400 mg bid
Other Name: Nexavar (Sorafenib)
Drug: IL-2
IL-2 3 MU per 5 day/week for 2 weeks every 4
Experimental: 2
Sorafenib 400 mg bid
Drug: Nexavar (Sorafenib)
400 mg bid
Other Name: Nexavar (Sorafenib)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609401

Locations
Italy
Istituto Tumori
Milano, Italy
Sponsors and Collaborators
Italian Trial in Medical Oncology
Investigators
Principal Investigator: Giuseppe Procopio, MD Istituto Tumori Milano
Study Director: E. Aitini, MD Ospedale di Mantova
Study Director: M. Bregni, MD Ospedale San Raffaele Milano
Study Director: G. Conti, MD Urologia - Ospedale di Como
Study Director: M. Maio, MD Immunologia Oncologica - Ospedale Le Scotte Siena
Study Director: G. Fasola, MD Ospedale di Udine
Study Director: V. Zagonel, MD Medicina Oncologica - Ospedale Fatebenefratelli - Roma
Study Director: S. Cascinu, MD Ospedale di Ancona
Study Director: G. Marini, MD Ospedale di Brescia
Study Director: A. Ardizzoia, MD Ospedale di Monza
Study Director: Sergio Ricci, Prof. Oncologia Medica - Ospedale Santa Chiara Pisa
Study Director: L. Cavanna, MD Oncologia Piacenza
Study Director: M. Aglietta, MD Ospedale di Candiolo Torino
Study Director: A. Bertolini, MD SOC Oncologia Medica Azienda Ospedaliera Valtellina
Study Director: Sergio Bracarda, MD Oncologia Medica Ospedale di Perugia
Study Director: L. ISA, MD A.O. Melegnano - Gorgonzola
Study Director: S. Monfardini, MD Oncologia Ospedale di Padova
Study Director: D. Amadori, MD IOR Ospedale di Forlì
Study Director: C. Porta, MD Ospedale San Matteo Pavia
  More Information

Additional Information:
No publications provided by Italian Trial in Medical Oncology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giuseppe Procopio, ITMO
ClinicalTrials.gov Identifier: NCT00609401     History of Changes
Other Study ID Numbers: EudraCT number 2006-003137-32, EudraCT number 2006-003137-32
Study First Received: January 11, 2008
Last Updated: February 25, 2009
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by Italian Trial in Medical Oncology:
Sorafenib
RCC
Metastatic disease

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Sorafenib
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014