Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer; Metastases
MeSH terms: Colorectal Neoplasms
Intervention: Best supportive care; Panitumumab
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).; Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.
Intervention MeSH terms: Panitumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Colorectal Cancer, Colon; Colorectal, Rectal Cancer, Cancer; Metastatic, EGFr, Clinical Trial; Panitumumab, ABX-EGF; Immunex, Abgenix, Amgen

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).
    

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.