Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects
NCT ID: NCT00865709
Last Updated: 2014-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
198 participants
INTERVENTIONAL
2009-03-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
Matching placebo + mFOLFOX6
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
Interventions
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Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Wichita, Kansas, United States
Metairie, Louisiana, United States
Brockton, Massachusetts, United States
Burlington, Massachusetts, United States
Dallas, Texas, United States
Antwerp, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Kecskemét, , Hungary
Szeged, , Hungary
Székesfehérvár, , Hungary
Castelfranco Veneto, Treviso, Italy
Genova, , Italy
Macerata, , Italy
Palermo, , Italy
Pordenone, , Italy
Torino, , Italy
Udine, , Italy
Verona, , Italy
Bialystok, , Poland
Elblag, , Poland
Gdansk, , Poland
Gdynia, , Poland
Krakow, , Poland
Krakow, , Poland
Olsztyn, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Alba Iulia, , Romania
Baia Mare, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova-Dolj, , Romania
Iași, , Romania
Oradea, , Romania
Suceava, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Astrakhan, , Russia
Chelyabinsk, , Russia
Irkutsk, , Russia
Ivanovo, , Russia
Izhevsk, , Russia
Kazan', , Russia
Khabarovsk, , Russia
Krasnodar, , Russia
Kursk, , Russia
Magnitogorsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Obninsk, , Russia
Pjatygorsk, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Sochi, , Russia
Syktyvkar, , Russia
Tula, , Russia
Ulyanovsk, , Russia
Vladimir, , Russia
Volgograd, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Manresa, Barcelona, Spain
Santander, Cantabria, Spain
Palma de Mallorca, Illes Baleares, Spain
Málaga, Málaga, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Madrid, , Spain
Cherkassy, , Ukraine
Dnipro, , Ukraine
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kryvyi Rih, , Ukraine
Luhansk, , Ukraine
Lviv, , Ukraine
Mariupol, , Ukraine
Sumy, , Ukraine
Uzhhorod, , Ukraine
Bristol, Avon, United Kingdom
Manchester, Manchester, United Kingdom
Liverpool, Merseyside, United Kingdom
Northwood, Middlesex, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Aberdeen, , United Kingdom
Belfast, , United Kingdom
Glasgow, , United Kingdom
Hull, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Portsmouth, , United Kingdom
Countries
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References
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Tabernero J, Garcia-Carbonero R, Cassidy J, Sobrero A, Van Cutsem E, Kohne CH, Tejpar S, Gladkov O, Davidenko I, Salazar R, Vladimirova L, Cheporov S, Burdaeva O, Rivera F, Samuel L, Bulavina I, Potter V, Chang YL, Lokker NA, O'Dwyer PJ. Sorafenib in combination with oxaliplatin, leucovorin, and fluorouracil (modified FOLFOX6) as first-line treatment of metastatic colorectal cancer: the RESPECT trial. Clin Cancer Res. 2013 May 1;19(9):2541-50. doi: 10.1158/1078-0432.CCR-13-0107. Epub 2013 Mar 26.
Related Links
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Click here and search for Bayer Product information provided by the EMA
Other Identifiers
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2008-005025-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13162
Identifier Type: -
Identifier Source: org_study_id