Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Neoplasm Metastasis

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

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Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Neoplastic Processes

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

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All Drugs and Chemicals

Analgesics

Sorafenib

Interleukin-2

Protein Kinase Inhibitors

Enzyme Inhibitors

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

Nexavar (Sorafenib)

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

IL-2

Giuseppe Procopio, MD

E. Aitini, MD

M. Bregni, MD

G. Conti, MD

M. Maio, MD

G. Fasola, MD

V. Zagonel, MD

S. Cascinu, MD

G. Marini, MD

A. Ardizzoia, MD

Sergio Ricci, Prof.

L. Cavanna, MD

M. Aglietta, MD

A. Bertolini, MD

Sergio Bracarda, MD

L. ISA, MD

S. Monfardini, MD

D. Amadori, MD

C. Porta, MD

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.

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.

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

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

Italian Trial in Medical Oncology

Giuseppe Procopio

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cyclophosphamide

Epirubicin

Single Arm: All patients receive sorafenib in addition to the established chemotherapy

Tablet, Sorafenib follows a patient specific escalation scheme starting with 200 mg daily up to a maximum dose of 800 mg daily during EC chemotherapy on day 2-19. The achieved dose will be continued during paclitaxel chemotherapy during week 1-11 all day

Sibylle Loibl, MD

The purpose of this study is to determine the efficacy and safety of sorafenib in the neoadjuvant setting in patients with primary breast cancer

Epirubicin/Cyclophosphamide followed by Paclitaxel (EC/P) is a well tolerated regimen with high clinical activity. Histopathological complete remission after preoperative chemotherapy has a direct correlation with the disease-free and overall survival. The aim of combining a chemotherapy regime with sorafenib in the neoadjuvant setting is to increase the locoregional and systemic outcome of these patients

Neoadjuvant Chemotherapy Including Sorafenib in Women With Previously Untreated Primary Breast Cancer

Phase II Study of Neoadjuvant Epirubicin, Cyclophosphamide (EC) + Sorafenib Followed by Paclitaxel (P) + Sorafenib in Women With Previously Untreated

Bayer

German Breast Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)	NCT00609401	Metastatic Dise... Renal Cell Carc...	Nexavar (Sorafe... IL-2	18 Years -	Italian Trial in Medical Oncology
Neoadjuvant Chemotherapy Including Sorafenib in Women With Previously Untreated Primary Breast Cancer	NCT00548899	Breast Cancer	Nexavar (Sorafe...	18 Years -	German Breast Group
Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)	NCT00609401	Metastatic Dise... Renal Cell Carc...	Nexavar (Sorafe... IL-2	18 Years -	Italian Trial in Medical Oncology
Neoadjuvant Chemotherapy Including Sorafenib in Women With Previously Untreated Primary Breast Cancer	NCT00548899	Breast Cancer	Nexavar (Sorafe...	18 Years -	German Breast Group
Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)	NCT00609401	Metastatic Dise... Renal Cell Carc...	Nexavar (Sorafe... IL-2	18 Years -	Italian Trial in Medical Oncology

Spots Global Cancer Trial Database for nexavar (sorafenib)