A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer
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 20mm per modified RECIST
- 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 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-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 CT scan
- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
(defined as > CTC grade 2 [CTCAE version 3.0])
- Peripheral sensory neuropathy with functional impairment