PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer; Colorectal Cancer; Rectal Cancer; Colon Cancer
• Intervention / Treatment: Drug: Panitumumab; Drug: mFOLFOX6; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Charleroi, Belgium, 6000
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • Libramont, Belgium, 6800
    • Research Site
  • Sint-Niklaas, Belgium, 9100
    • Research Site
• Canada
  • Quebec, Canada, G1R 2J6
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Research Site
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Research Site
    • Victoria, British Columbia, Canada, V8R 6V5
      • Research Site
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Research Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Research Site
    • Montreal, Quebec, Canada, H2X 3J4
      • Research Site
• Germany
  • Berlin, Germany, 13125
    • Research Site
  • Bielefeld, Germany, 33611
    • Research Site
  • Magdeburg, Germany, 39104
    • Research Site
  • München, Germany, 81737
    • Research Site
  • München, Germany, 81925
    • Research Site
  • Passau, Germany, 94032
    • Research Site
  • Regensburg, Germany, 93049
    • Research Site
  • Würzburg, Germany, 97070
    • Research Site
• Italy
  • Alba (CN), Italy, 12051
    • Research Site
  • Fano, Italy, 61032
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Mantova, Italy, 46100
    • Research Site
  • Udine, Italy, 33100
    • Research Site
  • Varese, Italy, 21100
    • Research Site
• Spain
  • AndalucÃ-a
    • Málaga, AndalucÃ-a, Spain, 29010
      • Research Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Research Site
  • Cataluña
    • Sabadell, Cataluña, Spain, 08208
      • Research Site
  • Comunidad
    • Elche, Comunidad, Spain, 03203
      • Research Site
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Research Site
  • Madrid
    • San Sebastián De Los Reyes, Madrid, Spain, 28702
      • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Site
    • Huntsville, Alabama, United States, 35805
      • Research Site
  • California
    • Berkeley, California, United States, 94704
      • Research Site
    • Beverly Hills, California, United States, 90211
      • Research Site
    • Burbank, California, United States, 91505
      • Research Site
    • Fountain Valley, California, United States, 92708
      • Research Site
    • La Verne, California, United States, 91750
      • Research Site
    • Orange, California, United States, 92868
      • Research Site
    • Riverside, California, United States, 92501
      • Research Site
    • Roseville, California, United States, 95661
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • Research Site
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Research Site
    • Waterbury, Connecticut, United States, 06708
      • Research Site
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Research Site
    • Coral Springs, Florida, United States, 33065
      • Research Site
    • Daytona Beach, Florida, United States, 32114
      • Research Site
    • Hollywood, Florida, United States, 33021
      • Research Site
    • Lake Worth, Florida, United States, 33467
      • Research Site
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Research Site
    • Augusta, Georgia, United States, 30901
      • Research Site
    • Savannah, Georgia, United States, 31405
      • Research Site
  • Idaho
    • Post Falls, Idaho, United States, 83854
      • Research Site
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Research Site
    • Peoria, Illinois, United States, 61615
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Research Site
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Research Site
    • Wichita, Kansas, United States, 67214
      • Research Site
  • Kentucky
    • Danville, Kentucky, United States, 40422
      • Research Site
    • Hazard, Kentucky, United States, 41701
      • Research Site
    • Paducah, Kentucky, United States, 42003
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Research Site
    • Bethesda, Maryland, United States, 20817
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Research Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Research Site
    • Lambertville, Michigan, United States, 48144
      • Research Site
    • Lansing, Michigan, United States, 48912
      • Research Site
  • New Jersey
    • Mountain Lakes, New Jersey, United States, 07046
      • Research Site
    • Sparta, New Jersey, United States, 07871
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Research Site
  • New York
    • Buffalo, New York, United States, 14215
      • Research Site
    • East Setauket, New York, United States, 11733
      • Research Site
    • Staten Island, New York, United States, 10301
      • Research Site
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Research Site
    • Raleigh, North Carolina, United States, 27607
      • Research Site
  • Ohio
    • Akron, Ohio, United States, 44304
      • Research Site
    • Columbus, Ohio, United States, 43228
      • Research Site
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19106
      • Research Site
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Research Site
  • Texas
    • Austin, Texas, United States, 78759
      • Research Site
    • Corpus Christi, Texas, United States, 78463
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
    • Round Rock, Texas, United States, 78665
      • Research Site
    • Temple, Texas, United States, 76508
      • Research Site
    • Tyler, Texas, United States, 75702
      • Research Site
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • Research Site
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Research Site
    • Newport News, Virginia, United States, 23601
      • Research Site
    • Newport News, Virginia, United States, 23606
      • Research Site
  • Washington
    • Spokane, Washington, United States, 99218
      • Research Site
    • Vancouver, Washington, United States, 98684
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
• Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
• Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
• Men or women 18 years of age or older
• Adequate hematologic, renal, hepatic, metabolic, and coagulation function

Exclusion Criteria:

• History of prior or concurrent central nervous system (CNS) metastases
• Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
• Clinically significant cardiac disease
• Clinically significant peripheral sensory neuropathy
• Active inflammatory bowel disease
• Recent gastroduodenal ulcer to be active or uncontrolled
• History of interstitial lung disease
• Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
• Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
• Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panitumumab Plus mFOLFOX6; Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU) (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.	Drug: Panitumumab; Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).; Other Names: Vectibix; Drug: mFOLFOX6; mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m^2) via ambulatory pump administered for a period of 46 to 48 hours.
Active Comparator: Bevacizumab Plus mFOLFOX6; Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.	Drug: mFOLFOX6; mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m^2) via ambulatory pump administered for a period of 46 to 48 hours.; Drug: Bevacizumab; Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF).; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Percentage of Participants With an Objective Response	Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Duration of Response	For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Time to Disease Progression	Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Time to Initial Objective Response	For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator's review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Resection Rate	The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)	PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)	PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Overall Survival in Participants With Wild-type RAS	Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Overall Survival in Participants With Wild-type RAS / BRAF	Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Percentage of Participants With an Objective Response for Participants With Wild-type RAS	Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF	Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.	From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Number of Participants With Adverse Events (AEs)	Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug.	The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus mFOLFOX arm and 7.3 months for Bevacizumab Plus mFOLFOX6 arm.

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Rivera F, Karthaus M, Hecht JR, Sevilla I, Forget F, Fasola G, Canon JL, Guan X, Demonty G, Schwartzberg LS. Final analysis of the randomised PEAK trial: overall survival and tumour responses during first-line treatment with mFOLFOX6 plus either panitumumab or bevacizumab in patients with metastatic colorectal carcinoma. Int J Colorectal Dis. 2017 Aug;32(8):1179-1190. doi: 10.1007/s00384-017-2800-1. Epub 2017 Apr 19.
• Schwartzberg LS, Rivera F, Karthaus M, Fasola G, Canon JL, Hecht JR, Yu H, Oliner KS, Go WY. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol. 2014 Jul 20;32(21):2240-7. doi: 10.1200/JCO.2013.53.2473. Epub 2014 Mar 31.
• Boeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Primary tumor sidedness has an impact on prognosis and treatment outcome in metastatic colorectal cancer: results from two randomized first-line panitumumab studies. Ann Oncol. 2017 Aug 1;28(8):1862-1868. doi: 10.1093/annonc/mdx119.
• Heinemann V, Rivera F, O'Neil BH, Stintzing S, Koukakis R, Terwey JH, Douillard JY. A study-level meta-analysis of efficacy data from head-to-head first-line trials of epidermal growth factor receptor inhibitors versus bevacizumab in patients with RAS wild-type metastatic colorectal cancer. Eur J Cancer. 2016 Nov;67:11-20. doi: 10.1016/j.ejca.2016.07.019. Epub 2016 Sep 1.
• Modest DP, Rivera F, Bachet JB, de Braud F, Pietrantonio F, Koukakis R, Demonty G, Douillard JY. Panitumumab-based maintenance after oxaliplatin discontinuation in metastatic colorectal cancer: A retrospective analysis of two randomised trials. Int J Cancer. 2019 Jul 15;145(2):576-585. doi: 10.1002/ijc.32110. Epub 2019 Jan 24.
• Peeters M, Forget F, Karthaus M, Valladares-Ayerbes M, Zaniboni A, Demonty G, Guan X, Rivera F. Exploratory pooled analysis evaluating the effect of sequence of biological therapies on overall survival in patients with RAS wild-type metastatic colorectal carcinoma. ESMO Open. 2018 Feb 24;3(2):e000297. doi: 10.1136/esmoopen-2017-000297. eCollection 2018.
• Taieb J, Geissler M, Rivera F, Karthaus M, Wilson R, Loupakis F, Price T, Tracy M, Burdon P, Peeters M. Relationship Between Tumor Response and Tumor-Related Symptoms in RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses From 3 Panitumumab Trials. Clin Colorectal Cancer. 2019 Dec;18(4):245-256.e5. doi: 10.1016/j.clcc.2019.07.009. Epub 2019 Jul 29.
• Taieb J, Rivera F, Siena S, Karthaus M, Valladares-Ayerbes M, Gallego J, Geissler M, Koukakis R, Demonty G, Peeters M. Exploratory analyses assessing the impact of early tumour shrinkage and depth of response on survival outcomes in patients with RAS wild-type metastatic colorectal cancer receiving treatment in three randomised panitumumab trials. J Cancer Res Clin Oncol. 2018 Feb;144(2):321-335. doi: 10.1007/s00432-017-2534-z. Epub 2017 Oct 28. Erratum In: J Cancer Res Clin Oncol. 2018 Feb 15;:
• Boeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies. Clin Colorectal Cancer. 2018 Sep;17(3):170-178.e3. doi: 10.1016/j.clcc.2018.03.005. Epub 2018 Mar 8.
• Peeters M, Price T, Taieb J, Geissler M, Rivera F, Canon JL, Pentheroudakis G, Koukakis R, Burdon P, Siena S. Relationships between tumour response and primary tumour location, and predictors of long-term survival, in patients with RAS wild-type metastatic colorectal cancer receiving first-line panitumumab therapy: retrospective analyses of the PRIME and PEAK clinical trials. Br J Cancer. 2018 Aug;119(3):303-312. doi: 10.1038/s41416-018-0165-z. Epub 2018 Jul 17.
• Sartore-Bianchi A, Garcia-Alfonso P, Geissler M, Kohne CH, Peeters M, Price T, Valladares-Ayerbes M, Zhang Y, Burdon P, Taieb J, Modest DP. Relationships Between Kohne Category/Baseline Tumor Load and Early Tumor Shrinkage, Depth of Response, and Outcomes in Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2021 Dec;20(4):305-313. doi: 10.1016/j.clcc.2021.05.007. Epub 2021 May 25.
• Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2009
• Primary Completion (Actual): May 30, 2012
• Study Completion (Actual): July 7, 2016

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: January 8, 2009
• First Posted (Estimate): January 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Bevacizumab; Colorectal Cancer; metastatic; Rectal Cancer; Colon Cancer; Panitumumab; Vectibix; modified FOLFOX 6; mFOLFOX 6; FOLFOX; Avastin; First-Line
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Panitumumab
• Other Study ID Numbers: 20070509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No