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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

Primary Purpose

Colon Cancer, Colorectal Cancer, Rectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Panitumumab
Bevacizumab
mFOLFOX6
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Colon Cancer, Colorectal Cancer, Rectal Cancer, Panitumumab, Vectibix, modified FOLFOX 6, mFOLFOX 6, FOLFOX, Bevacizumab, Avastin, First-Line, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Panitumumab Plus mFOLFOX6

Bevacizumab Plus mFOLFOX6

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 6, 2008
Last Updated
November 10, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00819780
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2009 (Actual)
Primary Completion Date
May 30, 2012 (Actual)
Study Completion Date
July 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Colorectal Cancer, Rectal Cancer, Metastatic Colorectal Cancer
Keywords
Colon Cancer, Colorectal Cancer, Rectal Cancer, Panitumumab, Vectibix, modified FOLFOX 6, mFOLFOX 6, FOLFOX, Bevacizumab, Avastin, First-Line, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panitumumab Plus mFOLFOX6
Arm Type
Experimental
Arm Description
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.
Arm Title
Bevacizumab Plus mFOLFOX6
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Other Intervention Name(s)
Vectibix
Intervention Description
Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF).
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Percentage of Participants With an Objective Response
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Duration of Response
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Time to Disease Progression
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Time to Initial Objective Response
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Resection Rate
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Overall Survival in Participants With Wild-type RAS
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Overall Survival in Participants With Wild-type RAS / BRAF
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Percentage of Participants With an Objective Response for Participants With Wild-type RAS
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF
Description
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.
Time Frame
From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
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.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
28424871
Citation
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.
Results Reference
background
PubMed Identifier
24687833
Citation
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.
Results Reference
background
PubMed Identifier
28449055
Citation
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.
Results Reference
background
PubMed Identifier
27592068
Citation
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.
Results Reference
background
PubMed Identifier
30614531
Citation
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.
Results Reference
background
PubMed Identifier
29531837
Citation
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.
Results Reference
background
PubMed Identifier
31515083
Citation
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.
Results Reference
background
PubMed Identifier
29080924
Citation
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;:
Results Reference
background
PubMed Identifier
29627309
Citation
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.
Results Reference
background
PubMed Identifier
30013091
Citation
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.
Results Reference
background
PubMed Identifier
34172397
Citation
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.
Results Reference
background
PubMed Identifier
26049686
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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