Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects

Last updated: November 25, 2014
Sponsor: Bayer
Overall Status: Completed

Phase

2

Condition

Colorectal Cancer

Metastatic Cancer

Treatment

N/A

Clinical Study ID

NCT00865709
13162
2008-005025-11
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 thathas 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

Exclusion Criteria:

  • Prior treatment with sorafenib

  • Clinical or radiographic evidence of brain metastasis

  • Major surgery, surgical biopsy, or significant traumatic injury within 28 days ofrandomization; evidence or history of bleeding diathesis or coagulopathy

  • Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growthfactor use within 28 days before randomization

  • Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months beforerandomization

  • Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within 28days before randomization

  • Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk ofthrombosis due to placement of a semi-permanent central venous port for administrationof 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'sparticipation in the study or evaluation of the study results

  • Use of any investigational drug within 28 days or 5 half-lives of that drug, whicheveris longer, before randomization

  • Subjects with metastatic CRC who are currently candidates for surgery with curativeintent

Study Design

Total Participants: 198
Study Start date:
March 01, 2009
Estimated Completion Date:
February 29, 2012

Connect with a study center

  • Antwerpen, 2020
    Belgium

    Site Not Available

  • Bruxelles - Brussel, 1070
    Belgium

    Site Not Available

  • Gent, 9000
    Belgium

    Site Not Available

  • Leuven, 3000
    Belgium

    Site Not Available

  • Liege, 4000
    Belgium

    Site Not Available

  • Budapest, 1106
    Hungary

    Site Not Available

  • Debrecen, 4032
    Hungary

    Site Not Available

  • Gyor, 9024
    Hungary

    Site Not Available

  • Kecskemet, 6000
    Hungary

    Site Not Available

  • Szeged, 6720
    Hungary

    Site Not Available

  • Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Castelfranco Veneto, Treviso 31033
    Italy

    Site Not Available

  • Genova, 16132
    Italy

    Site Not Available

  • Macerata, 62100
    Italy

    Site Not Available

  • Palermo, 90146
    Italy

    Site Not Available

  • Pordenone, 33170
    Italy

    Site Not Available

  • Torino, 10153
    Italy

    Site Not Available

  • Udine, 33100
    Italy

    Site Not Available

  • Verona, 37134
    Italy

    Site Not Available

  • Bialystok, 15-027
    Poland

    Site Not Available

  • Elblag, 82-300
    Poland

    Site Not Available

  • Gdansk, 80-952
    Poland

    Site Not Available

  • Gdynia, 81-519
    Poland

    Site Not Available

  • Krakow, 31-115
    Poland

    Site Not Available

  • Olsztyn, 10-228
    Poland

    Site Not Available

  • Warszawa, 02-781
    Poland

    Site Not Available

  • Wroclaw, 53-413
    Poland

    Site Not Available

  • Alba Iulia, 510039
    Romania

    Site Not Available

  • Baia Mare, 430031
    Romania

    Site Not Available

  • Bucharest, 022326
    Romania

    Site Not Available

  • Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Craiova-Dolj, 200535
    Romania

    Site Not Available

  • Iasi, 700106
    Romania

    Site Not Available

  • Oradea, 410032
    Romania

    Site Not Available

  • Suceava, 720237
    Romania

    Site Not Available

  • Timisoara, 300239
    Romania

    Site Not Available

  • Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • Astrakhan, 414041
    Russian Federation

    Site Not Available

  • Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • Ekaterinburg, 620036
    Russian Federation

    Site Not Available

  • Irkutsk, 664035
    Russian Federation

    Site Not Available

  • Ivanovo, 153013
    Russian Federation

    Site Not Available

  • Izhevsk, 426009
    Russian Federation

    Site Not Available

  • Kazan, 420029
    Russian Federation

    Site Not Available

  • Khabarovsk, 680022
    Russian Federation

    Site Not Available

  • Krasnodar, 350040
    Russian Federation

    Site Not Available

  • Kursk, 305035
    Russian Federation

    Site Not Available

  • Magnitogorsk, 455001
    Russian Federation

    Site Not Available

  • Moscow, 115478
    Russian Federation

    Site Not Available

  • Nizhny Novgorod, 603001
    Russian Federation

    Site Not Available

  • Novosibirsk, 630047
    Russian Federation

    Site Not Available

  • Obninsk, 249036
    Russian Federation

    Site Not Available

  • Pjatygorsk, 357502
    Russian Federation

    Site Not Available

  • Rostov-on-Don, 350086
    Russian Federation

    Site Not Available

  • Samara, 443031
    Russian Federation

    Site Not Available

  • Sochi, 354057
    Russian Federation

    Site Not Available

  • St. Petersburg, 198255
    Russian Federation

    Site Not Available

  • Syktyvkar, 167904
    Russian Federation

    Site Not Available

  • Tula, 300053
    Russian Federation

    Site Not Available

  • Ulyanovsk, 432063
    Russian Federation

    Site Not Available

  • Vladimir, 600020
    Russian Federation

    Site Not Available

  • Volgograd, 400138
    Russian Federation

    Site Not Available

  • Yaroslavl, 150054
    Russian Federation

    Site Not Available

  • L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Manresa, Barcelona 08240
    Spain

    Site Not Available

  • Santander, Cantabria 39008
    Spain

    Site Not Available

  • Palma de Mallorca, Illes Baleares 07010
    Spain

    Site Not Available

  • Barcelona, 08035
    Spain

    Site Not Available

  • Madrid, 28041
    Spain

    Site Not Available

  • empty

    Málaga, 29010
    Spain

    Site Not Available

  • Málaga, 29010
    Spain

    Site Not Available

  • Sevilla, 41013
    Spain

    Site Not Available

  • Valencia, 46009
    Spain

    Site Not Available

  • Cherkassy, 18009
    Ukraine

    Site Not Available

  • Dnepropetrovsk, 49102
    Ukraine

    Site Not Available

  • Dnipropetrovsk, 49055
    Ukraine

    Site Not Available

  • Donetsk, 83092
    Ukraine

    Site Not Available

  • Ivano-Frankovsk, 76000
    Ukraine

    Site Not Available

  • Kharkov, 61070
    Ukraine

    Site Not Available

  • Kiev, 03022
    Ukraine

    Site Not Available

  • Krivoy Rog, 50048
    Ukraine

    Site Not Available

  • Lugansk, 91047
    Ukraine

    Site Not Available

  • Lviv, 79031
    Ukraine

    Site Not Available

  • Mariupol, 87500
    Ukraine

    Site Not Available

  • Sumy, 40005
    Ukraine

    Site Not Available

  • Uzhgorod, 88014
    Ukraine

    Site Not Available

  • Bristol, Avon BS2 8ED
    United Kingdom

    Site Not Available

  • Liverpool, Merseyside L7 8XP
    United Kingdom

    Site Not Available

  • Northwood, Middlesex HA6 2RN
    United Kingdom

    Site Not Available

  • Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Aberdeen, AB25 2ZN
    United Kingdom

    Site Not Available

  • Belfast, BT7 1NN
    United Kingdom

    Site Not Available

  • Glasgow, G61 1BD
    United Kingdom

    Site Not Available

  • Hull, HU8 9HE
    United Kingdom

    Site Not Available

  • London, WC1E 6BT
    United Kingdom

    Site Not Available

  • Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Portsmouth, PO6 3LY
    United Kingdom

    Site Not Available

  • Wichita, Kansas 67214
    United States

    Site Not Available

  • Metairie, Louisiana 70006
    United States

    Site Not Available

  • Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Dallas, Texas 75246
    United States

    Site Not Available

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