Trial Condition(s):

Metastatic Colorectal Cancer

Study of Modified FOLFOX6 plus or minus Sorafenib in Stage IV metastatic colorectal carcinoma (mCRC) subjects

Bayer Identifier:

13162

ClinicalTrials.gov Identifier:

NCT00865709

EudraCT Number:

2008-005025-11

Study Completed

Trial Purpose

To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.

Inclusion Criteria
- Histological confirmation of adenocarcinoma of the colon or rectum
 - Tumor tissue sample available for KRAS and BRAF assessment
 - Measurable metastatic Stage IV disease including at least one measurable lesion that has not previously been radiated
 - No prior chemotherapy for metastatic CRC
 - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
 - Life expectancy of at least 12 weeks
 - Adequate bone marrow, liver, and renal function; adequate clotting parameters
Exclusion Criteria
- Prior treatment with sorafenib
 - Clinical or radiographic evidence of brain metastasis
 - Major surgery, surgical biopsy, or significant traumatic injury within 28 days of randomization; evidence or history of bleeding diathesis or coagulopathy
 - Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth factor use within 28 days before randomization
 - Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before randomization
 - Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within 28 days before randomization
 - Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semi-permanent central venous port for administration of chemotherapy is allowed. The use of coumadin and related compounds is excluded.)
 - Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg on repeated measurement) despite optimal medical management
 - Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization
 - Active cardiac disease including:
 -- Congestive heart failure
 -- Unstable angina or myocardial infarction within the 6 months before randomization
 -- Cardiac ventricular arrhythmias requiring antiarrhythmic treatment
 - Peripheral neuropathy > Grade 1 (CTCAE)
 - Known HIV infection or chronic hepatitis B or C infection
 - Any active infection >/= Grade 2 (CTCAE)
 - Any medical, psychological, or social condition that may interfere with the subject's participation in the study or evaluation of the study results
 - Use of any investigational drug within 28 days or 5 half-lives of that drug, whichever is longer, before randomization
 - Subjects with metastatic CRC who are currently candidates for surgery with curative intent

Trial Summary

Enrollment Goal
198
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Cancer Research UK - Glasgow

Glasgow, United Kingdom, G61 1BD

Status
Completed
 
Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Status
Completed
 
Locations

Nottingham City Hospital

Nottingham, United Kingdom, NG5 1PB

Status
Completed
 
Locations

Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Bristol Haematology and Oncology Centre

Bristol, United Kingdom, BS2 8ED

Status
Completed
 
Locations

Princess Royal Hospital

Hull, United Kingdom, HU8 9HE

Status
Completed
 
Locations

Queen's University

Belfast, United Kingdom, BT7 1NN

Status
Terminated
 
Locations

Via Christi Regional Medical Center

Wichita, United States, 67214

Status
Terminated
 
Locations

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-952

Status
Terminated
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 04-141

Status
Terminated
 
Locations

POZ nr 1 Szpitala Uniwersyteckiego

Krakow, Poland, 31-501

Status
Terminated
 
Locations

Wojewodzki Szpital Zespolony

Elblag, Poland, 82-300

Status
Terminated
 
Locations

Dolnoslaskie Centrum Onkologii

Wroclaw, Poland, 53-413

Status
Terminated
 
Locations

ASL TO/2 - Piemonte

Torino, Italy, 10153

Status
Terminated
 
Locations

A.O.U. Integrata Verona

Verona, Italy, 37134

Status
Terminated
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Terminated
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Active, not recruiting
 
Locations

Hospital Regional Carlos Haya

Málaga, Spain, 29010

Status
Completed
 
Locations

Hospital Universitario "Marqués de Valdecilla"

Santander, Spain, 39008

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Terminated
 
Locations

Hospital Universitari Son Espases

Palma de Mallorca, Spain, 07010

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Terminated
 
Locations

ZNA Middelheim

ANTWERPEN, Belgium, 2020

Status
Terminated
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Terminated
 
Locations

Petz Aladar Megyei Korhaz

Gyor, Hungary, 9024

Status
Terminated
 
Locations

University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4032

Status
Terminated
 
Locations

Bacs-Kiskun Country Hospital

Kecskemet, Hungary, 6000

Status
Terminated
 
Locations

Szegedi Tudomanyegyetem, SZAOTE

Szeged, Hungary, 6720

Status
Terminated
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
Locations

Queen Alexandra Hospital

Portsmouth, United Kingdom, PO6 3LY

Status
Terminated
 
Locations

University College London Hospitals

London, United Kingdom, WC1E 6BT

Status
Terminated
 
Locations

Royal Liverpool University Hospital

Liverpool, United Kingdom, L7 8XP

Status
Terminated
 
Locations

Lahey Clinic Medical Center

Burlington, United States, 01805

Status
Completed
 
Locations

Hematology and Oncology Specialists, LLC

Metairie, United States, 70006

Status
Terminated
 
Locations

Mary Crowley Medical Research Center

Dallas, United States, 75246

Status
Terminated
 
Locations

Medical Oncology/Hematology Associates

Brockton, United States, 02301

Status
Terminated
 
Locations

Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781

Status
Terminated
 
Locations

Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie

Bialystok, Poland, 15-027

Status
Terminated
 
Locations

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, Poland, 31-115

Status
Terminated
 
Locations

ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

Olsztyn, Poland, 10-228

Status
Terminated
 
Locations

Szpital Morski im. PCK Gdynskie Centrum Onkologii

Gdynia, Poland, 81-519

Status
Terminated
 
Locations

Oncology Research Center & Treatment Medical Center

Ekaterinburg, Russia, 620036

Status
Completed
 
Locations

Railways Hospital named after Semashko

Moscow, Russia, 129128

Status
Terminated
 
Locations

Regional Oncology Center

Chelyabinsk, Russia, 454087

Status
Completed
 
Locations

Research Institute of Oncology

Rostov-on-Don, Russia, 350086

Status
Completed
 
Locations

City Clinical Oncology Center

St. Petersburg, Russia, 197022

Status
Completed
 
Locations

Clinical Oncology Center

Magnitogorsk, Russia, 455001

Status
Completed
 
Locations

Krasnodar Region Oncology Centre

Krasnodar, Russia, 350040

Status
Completed
 
Locations

Regional Oncology Center

St. Petersburg, Russia, 191104

Status
Completed
 
Locations

Clinical Oncology Center

Arkhangelsk, Russia, 163045

Status
Completed
 
Locations

Kursk Regional Oncology Center

Kursk, Russia, 305035

Status
Completed
 
Locations

Regional Oncology Center

Irkutsk, Russia, 664035

Status
Completed
 
Locations

Oncology Center no 2

Sochi, Russia, 354057

Status
Terminated
 
Locations

Clinical Oncologz Center

Samara, Russia, 443031

Status
Terminated
 
Locations

Clinical Oncology Center no 1

Volgograd, Russia, 400138

Status
Terminated
 
Locations

Central Clinical Hospital

Moscow, Russia, 121356

Status
Completed
 
Locations

State Medical Institution Tula Regional Oncology Center

Tula, Russia, 300053

Status
Terminated
 
Locations

IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro

Genova, Italy, 16132

Status
Terminated
 
Locations

A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

Status
Terminated
 
Locations

AULSS 08 Asolo - Veneto

Castelfranco Veneto, Italy, 31033

Status
Terminated
 
Locations

A.O. Santa Maria degli Angeli

Pordenone, Italy, 33170

Status
Terminated
 
Locations

AUSL 6 Palermo - Sicilia

Palermo, Italy, 90146

Status
Terminated
 
Locations

ASUR Marche ZT09 Macerata

Macerata, Italy, 62100

Status
Terminated
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Hospital Althaia, Xarxa Assistencial de Manresa

Manresa, Spain, 08240

Status
Completed
 
Locations

Instituto Valenciano de Oncología

Valencia, Spain, 46009

Status
Terminated
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Terminated
 
Locations

CHC

LIEGE, Belgium, 4000

Status
Terminated
 
Locations

Institut Jules Bordet/Jules Bordet Instituut

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Terminated
 
Locations

ZNA Middelheim

ANTWERPEN, Belgium, 2020

Status
Completed
 
Locations

Szent Margit Hospital

Budapest, Hungary, 1032

Status
Terminated
 
Locations

Novosibirsk State-Funded Medical Institution

Novosibirsk, Russia, 630047

Status
Terminated
 
Locations

Medical Care Unit N 122

St. Petersburg, Russia, 194291

Status
Terminated
 
Locations

Ivanovo Regional Oncology Center

Ivanovo, Russia, 153013

Status
Terminated
 
Locations

Lugansk Regional Oncology Center

Lugansk, Ukraine, 91047

Status
Terminated
 
Locations

Regional Oncology Center

Uzhgorod , Ukraine, 88014

Status
Terminated
 
Locations

Regional Public Institution, Krivoy Rog Oncology Center

Krivoy Rog, Ukraine, 50048

Status
Terminated
 
Locations

Lviv State Regional Diagnostics and TreatmentOncology Center

Lviv, Ukraine, 79031

Status
Terminated
 
Locations

Donetsk Regional Oncological Center Regional Antitumor Cente

Donetsk, Ukraine, 83092

Status
Terminated
 
Locations

National Cancer Institute

Kiev, Ukraine, 03022

Status
Terminated
 
Locations

Kharkov Regional Oncology Center

Kharkov, Ukraine, 61070

Status
Terminated
 
Locations

Dnepropetrovsk Regional Oncology Center

Dnipropetrovsk, Ukraine, 49055

Status
Terminated
 
Locations

Mariupol City Interdistrict Oncology Center

Mariupol, Ukraine, 87500

Status
Terminated
 
Locations

Medical Oncology Center

Iasi, Romania, 700106

Status
Completed
 
Locations

Bajcsy Zsilinszky Hospital

Budapest, Hungary, 1106

Status
Terminated
 
Locations

Fejer megyei Szent Gyorgy Korhaz

Szekesfehervar, Hungary, 8000

Status
Terminated
 
Locations

Fovarosi Szent Laszlo Korhaz

Budapest, Hungary, 1097

Status
Terminated
 
Locations

Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

Moscow, Russia, 115478

Status
Completed
 
Locations

Clinical Oncology Hospital

Yaroslavl, Russia, 150054

Status
Completed
 
Locations

Medical Radiol. Research Centre of Minzdravsocrazvitie, FGBU

Obninsk, Russia, 249036

Status
Completed
 
Locations

Clinical Oncology Center

Ulyanovsk, Russia, 432063

Status
Completed
 
Locations

Clinical Oncology Center

Izhevsk, Russia, 426009

Status
Completed
 
Locations

Komi Republican Oncology Center

Syktyvkar, Russia, 167904

Status
Completed
 
Locations

City Hospital no 9

St. Petersburg, Russia, 197110

Status
Completed
 
Locations

Pjatigorsk Affiliate of Stavropol Clinical Oncology Center

Pjatygorsk, Russia, 357502

Status
Completed
 
Locations

Clinical Oncology Dispensary

Kazan, Russia, 420029

Status
Completed
 
Locations

Clinical Oncology Center

Vladimir , Russia, 600020

Status
Completed
 
Locations

Petrov Research Instutute of Oncology

St. Petersburg, Russia, 198255

Status
Terminated
 
Locations

Regional Oncologz Center

Astrakhan, Russia, 414041

Status
Terminated
 
Locations

Institutul Oncologic "Prof. Dr. Ioan Chiricuta"

Cluj-Napoca, Romania, 400015

Status
Terminated
 
Locations

Spitalul de urgenta "Sf. Ioan Cel Nou"

Suceava, Romania, 720237

Status
Terminated
 
Locations

Fundeni Clinical Institute

Bucharest, Romania, 022326

Status
Terminated
 
Locations

Alba Iulia Emergency Country Hospital

Alba Iulia, Romania, 510039

Status
Terminated
 
Locations

Federal State Institution

Nizhny Novgorod, Russia, 603001

Status
Terminated
 
Locations

Territorial Clinical Center of Oncology

Khabarovsk, Russia, 680022

Status
Terminated
 
Locations

City General Hosp #4, Dnepropetrovsk State Medical Academy

Dnepropetrovsk, Ukraine, 49102

Status
Terminated
 
Locations

Ivano-Frankovsk Regional Oncology Center MU

Ivano-Frankovsk, Ukraine, 76000

Status
Terminated
 
Locations

Communal establishment "Cherkassy Regional Oncology Center"

Cherkassy, Ukraine, 18009

Status
Terminated
 
Locations

Sumy Regional Oncology Center

Sumy, Ukraine, 40005

Status
Terminated
 
Locations

Oncomed SRL

Timisoara, Romania, 300239

Status
Terminated
 
Locations

Meditech SRL

Craiova-Dolj, Romania, 200535

Status
Completed
 
Locations

OradeaCountry Emergency Clinical Hospital

Oradea, Romania, 410032

Status
Terminated
 
Locations

Emergency Country Hospital Baia Mare "Dr. Constantin Opris"

Baia Mare, Romania, 430031

Status
Completed
 
Locations

Oncomed SRL

Timisoara, Romania, 300239

Status
Completed
 
Locations

Prof. Dr. Alexandru Trestioreanu Institute of Oncology

Bucharest, Romania, 022328

Status
Terminated
 

Trial Design