Effect of Panitumumab on the Pharmacokinetics of Irinotecan
NCT ID: NCT00563316
Last Updated: 2016-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2008-03-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Panitumumab + Irinotecan
Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
Panitumumab
The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter.
Irinotecan
The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.
Interventions
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Panitumumab
The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter.
Irinotecan
The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of ≥ 3 months as documented by the investigator
* Baseline actual body weight ≤ 160 kg
* Competent to comprehend, sign, and date a written Institutional Review Board (IRB) approved informed consent form before any study-specific procedures are performed
Exclusion Criteria
* Known presence of central nervous systems (CNS) metastases
* Any prior malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent with no evidence of disease ≤ 2 years before enrollment
* History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as \> Common Terminology Criteria for Adverse Events (CTCAE version 3) grade 2
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
* UGT1A1\*28 TA7/7, TA7/8, TA8/8 genetic polymorphisms; Gilbert's Disease
* Treatment with CYP3A4 enzyme inhibiting or inducing medications ≤ 2 weeks before enrollment
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
* Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before enrollment
* Subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine), however corticosteroids are allowed
* Major surgery \< 28 days prior to enrollment or minor surgery (excluding catheter placement) \< 14 days before enrollment
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Billings, Montana, United States
Research Site
Billings, Montana, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Vancouver, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Countries
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References
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Yang BB, Wu CY, Chen E, Infante JR, Chen A, Gao B, Smith B, Litten J, Kennecke H. Pharmacokinetics of Irinotecan With and Without Panitumumab Coadministration in Patients With Metastatic Colorectal Cancer. Clin Pharmacol Drug Dev. 2013 Jul;2(3):205-12. doi: 10.1002/cpdd.35. Epub 2013 May 15.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20062010
Identifier Type: -
Identifier Source: org_study_id
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