check_circleStudy Completed

Metastatic Colorectal Cancer

Bayer Identifier:

13162

ClinicalTrials.gov Identifier:

NCT00865709

EudraCT Number:

2008-005025-11

EU CT Number:

Not Available
Study of Modified FOLFOX6 plus or minus Sorafenib in Stage IV metastatic colorectal carcinoma (mCRC) subjects

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
March 2009 - February 2012
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Cancer Research UK - GlasgowGlasgow, G61 1BD, United Kingdom
Completed
Aberdeen Royal InfirmaryAberdeen, AB25 2ZN, United Kingdom
Completed
Nottingham City HospitalNottingham, NG5 1PB, United Kingdom
Completed
Mount Vernon HospitalNorthwood, HA6 2RN, United Kingdom
Completed
Bristol Haematology and Oncology CentreBristol, BS2 8ED, United Kingdom
Completed
Princess Royal HospitalHull, HU8 9HE, United Kingdom
Terminated
Queen's UniversityBelfast, BT7 1NN, United Kingdom
Terminated
Via Christi Regional Medical CenterWichita, 67214, United States
Terminated
Uniwersyteckie Centrum KliniczneGdansk, 80-952, Poland
Terminated
Wojskowy Instytut MedycznyWarszawa, 04-141, Poland
Terminated
POZ nr 1 Szpitala UniwersyteckiegoKrakow, 31-501, Poland
Terminated
Wojewodzki Szpital ZespolonyElblag, 82-300, Poland
Terminated
Dolnoslaskie Centrum OnkologiiWroclaw, 53-413, Poland
Terminated
ASL TO/2 - PiemonteTorino, 10153, Italy
Terminated
A.O.U. Integrata VeronaVerona, 37134, Italy
Terminated
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Active, not recruiting
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Hospital Regional Carlos HayaMálaga, 29010, Spain
Completed
Hospital Universitario "Marqués de Valdecilla"Santander, 39008, Spain
Terminated
Ciutat Sanitària i Universitària de BellvitgeL'Hospitalet de Llobregat, 08907, Spain
Completed
Hospital Universitari Son EspasesPalma de Mallorca, 07010, Spain
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Institut Català d'OncologiaL'Hospitalet de Llobregat, 08907, Spain
Terminated
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES - BRUSSEL, 1070, Belgium
Terminated
ZNA MiddelheimANTWERPEN, 2020, Belgium
Terminated
UZ GentGENT, 9000, Belgium
Terminated
Petz Aladar Megyei KorhazGyor, 9024, Hungary
Terminated
University of Debrecen Medical&Health Science CenterDebrecen, 4032, Hungary
Terminated
Bacs-Kiskun Country HospitalKecskemet, 6000, Hungary
Terminated
Szegedi Tudomanyegyetem, SZAOTESzeged, 6720, Hungary
Completed
Christie HospitalManchester, M20 4BX, United Kingdom
Completed
Freeman HospitalNewcastle Upon Tyne, NE7 7DN, United Kingdom
Terminated
Queen Alexandra HospitalPortsmouth, PO6 3LY, United Kingdom
Terminated
University College London HospitalsLondon, WC1E 6BT, United Kingdom
Terminated
Royal Liverpool University HospitalLiverpool, L7 8XP, United Kingdom
Completed
Lahey Clinic Medical CenterBurlington, 01805, United States
Terminated
Hematology and Oncology Specialists, LLCMetairie, 70006, United States
Terminated
Mary Crowley Medical Research CenterDallas, 75246, United States
Terminated
Medical Oncology/Hematology AssociatesBrockton, 02301, United States
Terminated
Centrum Onkologii - Instytut im. M.Sklodowskiej-CurieWarszawa, 02-781, Poland
Terminated
Bialostockie Centrum Onkologii im. M. Sklodowskiej-CurieBialystok, 15-027, Poland
Terminated
Centrum Onkologii Instytut im. M. Sklodowskiej-CurieKrakow, 31-115, Poland
Terminated
ZOZ MSWiA z Warminsko-Mazurskim Centrum OnkologiiOlsztyn, 10-228, Poland
Terminated
Szpital Morski im. PCK Gdynskie Centrum OnkologiiGdynia, 81-519, Poland
Completed
Oncology Research Center & Treatment Medical CenterEkaterinburg, 620036, Russia
Terminated
Railways Hospital named after SemashkoMoscow, 129128, Russia
Completed
Regional Oncology CenterChelyabinsk, 454087, Russia
Completed
Research Institute of OncologyRostov-on-Don, 350086, Russia
Completed
City Clinical Oncology CenterSt. Petersburg, 197022, Russia
Completed
Clinical Oncology CenterMagnitogorsk, 455001, Russia
Completed
Krasnodar Region Oncology CentreKrasnodar, 350040, Russia
Completed
Regional Oncology CenterSt. Petersburg, 191104, Russia
Completed
Clinical Oncology CenterArkhangelsk, 163045, Russia
Completed
Kursk Regional Oncology CenterKursk, 305035, Russia
Completed
Regional Oncology CenterIrkutsk, 664035, Russia
Terminated
Oncology Center no 2Sochi, 354057, Russia
Terminated
Clinical Oncologz CenterSamara, 443031, Russia
Terminated
Clinical Oncology Center no 1Volgograd, 400138, Russia
Completed
Central Clinical HospitalMoscow, 121356, Russia
Terminated
State Medical Institution Tula Regional Oncology CenterTula, 300053, Russia
Terminated
POZ nr 1 Szpitala UniwersyteckiegoKrakow, 31-501, Poland
Terminated
IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca CancroGenova, 16132, Italy
Terminated
A.O.U. Santa Maria Misericordia UDUdine, 33100, Italy
Terminated
AULSS 08 Asolo - VenetoCastelfranco Veneto, 31033, Italy
Terminated
A.O. Santa Maria degli AngeliPordenone, 33170, Italy
Terminated
AUSL 6 Palermo - SiciliaPalermo, 90146, Italy
Terminated
ASUR Marche ZT09 MacerataMacerata, 62100, Italy
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Hospital Althaia, Xarxa Assistencial de ManresaManresa, 08240, Spain
Terminated
Instituto Valenciano de OncologíaValencia, 46009, Spain
Terminated
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Terminated
CHCLIEGE, 4000, Belgium
Terminated
Institut Jules Bordet/Jules Bordet InstituutBRUXELLES - BRUSSEL, 1000, Belgium
Completed
ZNA MiddelheimANTWERPEN, 2020, Belgium
Terminated
Szent Margit HospitalBudapest, 1032, Hungary
Terminated
Novosibirsk State-Funded Medical InstitutionNovosibirsk, 630047, Russia
Terminated
Medical Care Unit N 122St. Petersburg, 194291, Russia
Terminated
Ivanovo Regional Oncology CenterIvanovo, 153013, Russia
Terminated
Lugansk Regional Oncology CenterLugansk, 91047, Ukraine
Terminated
Regional Oncology CenterUzhgorod, 88014, Ukraine
Terminated
Regional Public Institution, Krivoy Rog Oncology CenterKrivoy Rog, 50048, Ukraine
Terminated
Lviv State Regional Diagnostics and TreatmentOncology CenterLviv, 79031, Ukraine
Terminated
Donetsk Regional Oncological Center Regional Antitumor CenteDonetsk, 83092, Ukraine
Terminated
National Cancer InstituteKiev, 03022, Ukraine
Terminated
Kharkov Regional Oncology CenterKharkov, 61070, Ukraine
Terminated
Dnepropetrovsk Regional Oncology CenterDnipropetrovsk, 49055, Ukraine
Terminated
Mariupol City Interdistrict Oncology CenterMariupol, 87500, Ukraine
Terminated
National Cancer InstituteKiev, 03022, Ukraine
Completed
Medical Oncology CenterIasi, 700106, Romania
Terminated
Bajcsy Zsilinszky HospitalBudapest, 1106, Hungary
Terminated
Fejer megyei Szent Gyorgy KorhazSzekesfehervar, 8000, Hungary
Terminated
Fovarosi Szent Laszlo KorhazBudapest, 1097, Hungary
Completed
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115478, Russia
Completed
Clinical Oncology HospitalYaroslavl, 150054, Russia
Completed
Medical Radiol. Research Centre of Minzdravsocrazvitie, FGBUObninsk, 249036, Russia
Completed
Clinical Oncology CenterUlyanovsk, 432063, Russia
Completed
Clinical Oncology CenterIzhevsk, 426009, Russia
Completed
Komi Republican Oncology CenterSyktyvkar, 167904, Russia
Completed
City Hospital no 9St. Petersburg, 197110, Russia
Completed
Pjatigorsk Affiliate of Stavropol Clinical Oncology CenterPjatygorsk, 357502, Russia
Completed
Clinical Oncology DispensaryKazan, 420029, Russia
Completed
Clinical Oncology CenterVladimir, 600020, Russia
Terminated
Petrov Research Instutute of OncologySt. Petersburg, 198255, Russia
Terminated
Regional Oncologz CenterAstrakhan, 414041, Russia
Terminated
Institutul Oncologic "Prof. Dr. Ioan Chiricuta"Cluj-Napoca, 400015, Romania
Terminated
Spitalul de urgenta "Sf. Ioan Cel Nou"Suceava, 720237, Romania
Terminated
Fundeni Clinical InstituteBucharest, 022326, Romania
Terminated
Alba Iulia Emergency Country HospitalAlba Iulia, 510039, Romania
Terminated
Federal State InstitutionNizhny Novgorod, 603001, Russia
Terminated
Territorial Clinical Center of OncologyKhabarovsk, 680022, Russia
Terminated
City General Hosp #4, Dnepropetrovsk State Medical AcademyDnepropetrovsk, 49102, Ukraine
Terminated
Ivano-Frankovsk Regional Oncology Center MUIvano-Frankovsk, 76000, Ukraine
Terminated
Communal establishment "Cherkassy Regional Oncology Center"Cherkassy, 18009, Ukraine
Terminated
Sumy Regional Oncology CenterSumy, 40005, Ukraine
Terminated
Oncomed SRLTimisoara, 300239, Romania
Completed
Meditech SRLCraiova-Dolj, 200535, Romania
Terminated
OradeaCountry Emergency Clinical HospitalOradea, 410032, Romania
Completed
Emergency Country Hospital Baia Mare "Dr. Constantin Opris"Baia Mare, 430031, Romania
Completed
Oncomed SRLTimisoara, 300239, Romania
Terminated
Prof. Dr. Alexandru Trestioreanu Institute of OncologyBucharest, 022328, Romania

Primary Outcome

  • Progression-Free Survival (PFS)
    date_rangeTime Frame:
    From randomization of the first subject until 23 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall Survival (OS)
    date_rangeTime Frame:
    From randomization of the first subject until 33 months later
    enhanced_encryption
    Safety Issue:
    No
  • Time to Progression (TTP)
    date_rangeTime Frame:
    From randomization of the first subject until 23 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall response
    date_rangeTime Frame:
    From randomization of the first subject until 23 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Response
    date_rangeTime Frame:
    From randomization of the first subject until 23 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects previously untreated for Stage IV disease
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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