Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
Metastatic Colorectal Cancer
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
Experimental
Active Comparator
Panitumumab Plus FOLFIRI
FOLFIRI Alone
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.