Back to resultsEvaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer, Metastases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Best supportive care
Panitumumab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Colon, Colorectal, Rectal Cancer, Cancer, Metastatic, EGFr, Clinical Trial, Panitumumab, ABX-EGF, Immunex, Abgenix, Amgen
Eligibility Criteria
Inclusion Criteria: Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy) Metastatic colorectal carcinoma Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen Unidimensionally measurable disease Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer Adequate hematologic, renal and hepatic function Exclusion Criteria: Symptomatic brain metastases requiring treatment History or evidence of interstitial pneumonitis or pulmonary fibrosis Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment Prior epidermal growth factor receptor (EGFr) targeting therapies Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Panitumumab plus best supportive care
Best Supportive Care
Arm Description
Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional guidelines.
Best supportive care will be defined in this study as the best care available as judged appropriate by the investigator and according to institutional guidelines and will include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care will not include anti-neoplastic chemotherapy.
Outcomes
Primary Outcome Measures
Progression-free Survival Time
Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.
Secondary Outcome Measures
Overall Survival
Kaplan-Meier estimates of median time from randomization to death.
Objective Tumor Response
Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.
Duration of Response
Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).
Time to Response
Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.
Time to Disease Progression
Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)
Time to Treatment Failure
Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.
Duration of Stable Disease
Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00113763
Brief Title
Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
Official Title
An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2004 (Actual)
Primary Completion Date
October 1, 2008 (Actual)
Study Completion Date
June 1, 2009 (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 determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastases
Keywords
Metastatic Colorectal Cancer, Colon, Colorectal, Rectal Cancer, Cancer, Metastatic, EGFr, Clinical Trial, Panitumumab, ABX-EGF, Immunex, Abgenix, Amgen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
463 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Panitumumab plus best supportive care
Arm Type
Experimental
Arm Description
Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional guidelines.
Arm Title
Best Supportive Care
Arm Type
Other
Arm Description
Best supportive care will be defined in this study as the best care available as judged appropriate by the investigator and according to institutional guidelines and will include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care will not include anti-neoplastic chemotherapy.
Intervention Type
Other
Intervention Name(s)
Best supportive care
Intervention Description
Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases).
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Other Intervention Name(s)
ABX-EGF
Intervention Description
Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.
Primary Outcome Measure Information:
Title
Progression-free Survival Time
Description
Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.
Time Frame
From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Kaplan-Meier estimates of median time from randomization to death.
Time Frame
From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group.
Title
Objective Tumor Response
Description
Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.
Time Frame
From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
Title
Duration of Response
Description
Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).
Time Frame
From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
Title
Time to Response
Description
Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.
Time Frame
From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
Title
Time to Disease Progression
Description
Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)
Time Frame
From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
Title
Time to Treatment Failure
Description
Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.
Time Frame
From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
Title
Duration of Stable Disease
Description
Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions.
Time Frame
From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
Metastatic colorectal carcinoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen
Unidimensionally measurable disease
Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
Adequate hematologic, renal and hepatic function
Exclusion Criteria:
Symptomatic brain metastases requiring treatment
History or evidence of interstitial pneumonitis or pulmonary fibrosis
Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
Prior epidermal growth factor receptor (EGFr) targeting therapies
Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
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Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://www.vectibix.com/
Description
FDA-approved Drug Labeling
Learn more about this trial
Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
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