Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects
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
2 other identifiers
interventional
198
10 countries
116
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Typical duration for phase_2
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
March 20, 2012
CompletedDecember 11, 2014
November 1, 2014
1.8 years
February 2, 2009
January 31, 2012
November 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.
From randomization of the first subject until 23 months later, assessed every 8 weeks.
Secondary Outcomes (4)
Overall Survival (OS)
From randomization of the first subject until 33 months later.
Time to Progression (TTP)
From randomization of the first subject until 23 months later, assessed every 8 weeks.
Overall Response
From randomization of the first subject until 23 months later, assessed every 8 weeks.
Duration of Response
From randomization of the first subject until 23 months later, assessed every 8 weeks
Study Arms (2)
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6
EXPERIMENTALSubjects 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
PLACEBO COMPARATORSubjects 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
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)
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
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
Unknown Facility
Wichita, Kansas, 67214, United States
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Metairie, Louisiana, 70006, United States
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Brockton, Massachusetts, 02301, United States
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Burlington, Massachusetts, 01805, United States
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Dallas, Texas, 75246, United States
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Antwerp, 2020, Belgium
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Bruxelles - Brussel, 1000, Belgium
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Bruxelles - Brussel, 1070, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Budapest, 1032, Hungary
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Budapest, 1097, Hungary
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Budapest, 1106, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Kecskemét, 6000, Hungary
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Szeged, 6720, Hungary
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SzĂ©kesfehĂ©rvĂ¡r, 8000, Hungary
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Castelfranco Veneto, Treviso, 31033, Italy
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Genova, 16132, Italy
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Macerata, 62100, Italy
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Palermo, 90146, Italy
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Pordenone, 33170, Italy
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Torino, 10153, Italy
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Udine, 33100, Italy
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Verona, 37134, Italy
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Bialystok, 15-027, Poland
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Elblag, 82-300, Poland
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Gdansk, 80-952, Poland
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Gdynia, 81-519, Poland
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Krakow, 31-115, Poland
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Krakow, 31-501, Poland
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Olsztyn, 10-228, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-141, Poland
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Wroclaw, 53-413, Poland
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Alba Iulia, 510039, Romania
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Baia Mare, 430031, Romania
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Bucharest, 022326, Romania
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Bucharest, 022328, Romania
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Cluj-Napoca, 400015, Romania
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Craiova-Dolj, 200535, Romania
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Iași, 700106, Romania
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Oradea, 410032, Romania
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Suceava, 720237, Romania
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Timișoara, 300239, Romania
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Arkhangelsk, 163045, Russia
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Astrakhan, 414041, Russia
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Chelyabinsk, 454087, Russia
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Irkutsk, 664035, Russia
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Ivanovo, 153013, Russia
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Izhevsk, 426009, Russia
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Kazan', 420029, Russia
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Khabarovsk, 680022, Russia
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Krasnodar, 350040, Russia
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Kursk, 305035, Russia
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Magnitogorsk, 455001, Russia
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Moscow, 115478, Russia
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Moscow, 121356, Russia
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Moscow, 129128, Russia
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Nizhny Novgorod, 603001, Russia
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Novosibirsk, 630047, Russia
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Obninsk, 249036, Russia
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Pjatygorsk, 357502, Russia
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Rostov-on-Don, 350086, Russia
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Saint Petersburg, 191104, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197110, Russia
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Saint Petersburg, 198255, Russia
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Samara, 443031, Russia
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Sochi, 354057, Russia
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Syktyvkar, 167904, Russia
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Tula, 300053, Russia
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Ulyanovsk, 432063, Russia
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Vladimir, 600020, Russia
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Volgograd, 400138, Russia
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Yaroslavl, 150054, Russia
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Yekaterinburg, 620036, Russia
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Manresa, Barcelona, 08240, Spain
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Santander, Cantabria, 39008, Spain
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Palma de Mallorca, Illes Baleares, 07010, Spain
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MĂ¡laga, MĂ¡laga, 29010, Spain
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Seville, Sevilla, 41013, Spain
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Valencia, Valencia, 46009, Spain
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Valencia, Valencia, 46010, Spain
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Madrid, 28041, Spain
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Cherkassy, 18009, Ukraine
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Dnipro, 49102, Ukraine
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Dnipropetrovsk, 49055, Ukraine
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Donetsk, 83092, Ukraine
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Ivano-Frankivsk, 76000, Ukraine
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Kharkiv, 61070, Ukraine
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Kiev, 03022, Ukraine
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Kryvyi Rih, 50048, Ukraine
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Luhansk, 91047, Ukraine
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Lviv, 79031, Ukraine
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Mariupol, 87500, Ukraine
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Sumy, 40005, Ukraine
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Uzhhorod, 88014, Ukraine
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Bristol, Avon, BS2 8ED, United Kingdom
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Manchester, Manchester, M20 4BX, United Kingdom
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Liverpool, Merseyside, L7 8XP, United Kingdom
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Northwood, Middlesex, HA6 2RN, United Kingdom
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Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
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Aberdeen, AB25 2ZN, United Kingdom
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Belfast, BT7 1NN, United Kingdom
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Glasgow, G61 1BD, United Kingdom
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Hull, HU8 9HE, United Kingdom
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London, WC1E 6BT, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
Related Publications (1)
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.
PMID: 23532888RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2009
First Posted
March 19, 2009
Study Start
March 1, 2009
Primary Completion
January 1, 2011
Study Completion
February 1, 2012
Last Updated
December 11, 2014
Results First Posted
March 20, 2012
Record last verified: 2014-11