Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Panitumumab; FOLFIRI
Intervention description: Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.; 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.
Intervention MeSH terms: Panitumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oncology; Cancer; Metastatic Colorectal Cancer; EGFr; Panitumumab; Clinical Trial; Amgen

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.
    

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