Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Irinotecan; Panitumumab

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