Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC) (ROSORC)
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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 |
- 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 |
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| Italy | |
| Istituto Tumori | |
| Milano, Italy | |
| 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
| 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, 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 May 22, 2013