Back to resultsComparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Panitumumab
FOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Oncology, Cancer, Metastatic Colorectal Cancer, EGFr, Panitumumab, Clinical Trial, Amgen
Eligibility Criteria
Inclusion Criteria: Man or woman at least 18 years old Diagnosis of metastatic colorectal cancer (mCRC) One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2 Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses Adequate hematologic, renal, and hepatic functions Negative pregnancy test within 72 hours of enrollment Other protocol-specified criteria may apply Exclusion Criteria: History of or known presence of central nervous system (CNS) metastases History of another primary cancer within 5 years of randomization Prior irinotecan therapy Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors Any investigational agent or therapy within 30 days before randomization Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin History of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan Active inflammatory bowel disease or other bowel disease causing chronic diarrhea Known positive tests for human immunodefiency virus (HIV), hepatitis C viris (HCV), acute or chronic active hepatitis B virus (HBV) Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization Pregnant or breast-feeding Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men) Other protocol-specified criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Panitumumab Plus FOLFIRI
FOLFIRI Alone
Arm Description
Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Overall Survival
Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.
Secondary Outcome Measures
Percentage of Participants With an Objective Response
Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.
Time to Disease Progression
Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Duration of Response
Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Number of Participants With Adverse Events (AEs)
A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00339183
Brief Title
Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
Official Title
A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2006 (Actual)
Primary Completion Date
April 1, 2009 (Actual)
Study Completion Date
November 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Oncology, Cancer, Metastatic Colorectal Cancer, EGFr, Panitumumab, Clinical Trial, Amgen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Panitumumab Plus FOLFIRI
Arm Type
Experimental
Arm Description
Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
Arm Title
FOLFIRI Alone
Arm Type
Active Comparator
Arm Description
Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Other Intervention Name(s)
Vectibix®
Intervention Description
Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m^2, leucovorin 400 mg/m^2 racemate (or 200 mg/m^2 I-leucovorin), 5-FU bolus 400 mg/m^2, 5-FU infusion 2400 mg/m^2.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Time Frame
From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.
Title
Overall Survival
Description
Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.
Time Frame
From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Objective Response
Description
Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.
Time Frame
Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.
Title
Time to Disease Progression
Description
Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Time Frame
From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Title
Duration of Response
Description
Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Time Frame
From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Title
Number of Participants With Adverse Events (AEs)
Description
A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?"
Time Frame
From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Man or woman at least 18 years old
Diagnosis of metastatic colorectal cancer (mCRC)
One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy
Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy
At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses
Adequate hematologic, renal, and hepatic functions
Negative pregnancy test within 72 hours of enrollment
Other protocol-specified criteria may apply
Exclusion Criteria:
History of or known presence of central nervous system (CNS) metastases
History of another primary cancer within 5 years of randomization
Prior irinotecan therapy
Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors
Any investigational agent or therapy within 30 days before randomization
Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin
History of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
Known positive tests for human immunodefiency virus (HIV), hepatitis C viris (HCV), acute or chronic active hepatitis B virus (HBV)
Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization
Pregnant or breast-feeding
Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men)
Other protocol-specified criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
24356622
Citation
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Results Reference
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PubMed Identifier
20921462
Citation
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Results Reference
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Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
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