PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Panitumumab; FOLFOX regimen
Intervention description: Panitumumab 6 mg/kg over on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.; The FOLFOX regimen consisted of oxaliplatin 85 mg/m^2 intravenous (IV) infusion on Day 1, leucovorin, 200 mg/m^2 (racemate) on Days 1 and 2 and 5-fluorouracil 400 mg/m^2 IV bolus followed by 600 mg/m^2 IV infusion over 22 hours on Days 1 and 2. Each cycle was 14 days.
Intervention MeSH terms: Panitumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oncology; Cancer; metastatic colorectal cancer; EGFr; Panitumumab; Clinical Trail; Amgen

Summary:

      The purpose of this study is to determine the treatment effect of panitumumab in combination
      with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman at least 18 years old

          -  Diagnosis of metastatic colorectal cancer

          -  At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Paraffin-embedded tumor tissue from the primary tumor or metastasis available for
             central analyse Exclusion Criteria:

          -  History or known presence of central nervous system (CNS) metastases

          -  History of another primary cancer, except: Curatively treated in situ cervical cancer,
             or Curatively resected non-melanoma skin cancer, or Other primary solid tumor
             curatively treated with no known active disease present and no treatment administered
             for ≥ 5 years before randomization

          -  Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal
             carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior
             fluoropyrimidine therapy administered solely for the purpose of radiosensitization

          -  Prior oxaliplatin therapy

          -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or
             treatment with small molecule EGFr inhibitors (eg, erlotinib)

          -  Clinically significant cardiovascular disease (including myocardial infarction,
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
             arrhythmia) 1 year prior to randomization 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 (CTC) grade 2 [CTCAE version 3.0])

          -  Peripheral sensory neuropathy with functional impairment