Clinical trial NCT00079274 (phase 3, status: completed)
Conditions: adenocarcinoma of the colon, stage iii colon cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3
Drugs: irinotecan hydrochloride, oxaliplatin, leucovorin calcium, fluorouracil, locally directed therapy
SMILES: CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the colon

               -  Stage III disease

               -  No resected stage IV disease

          -  No rectal cancer

               -  Gross inferior (caudad) margin of the primary tumor must be ≥ 12 cm from the anal
                  verge by rigid proctoscopy

          -  Stage III tumor must have been completely resected within the past 56 days

               -  Must have documented en bloc resection in patients with tumor adherence to
                  adjacent structures

               -  Tumor-related obstructions and colonic perforation are allowed

               -  Tumor samples must be available

          -  At least 1 pathologically confirmed positive lymph node

               -  No evidence of residual involved lymph node disease

          -  Synchronous primary colon cancer allowed

          -  No distant metastatic disease

          -  Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Creatinine ≤ 1.5 times ULN

          -  No uncontrolled high blood pressure

          -  No unstable angina

          -  No symptomatic congestive heart failure

          -  No myocardial infarction with the past 6 months

          -  No New York Heart Association class III or IV heart disease

          -  No symptomatic pulmonary fibrosis

          -  No symptomatic interstitial pneumonitis

          -  No prior allergic reaction (known sensitivity) to chimerized or murine monoclonal
             antibody therapy

          -  No known allergy to platinum compounds

          -  No documented presence of human anti-mouse antibodies (HAMA)

          -  No active uncontrolled bacterial, viral, or systemic fungal infection

          -  HIV negative

          -  No clinically defined AIDS

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No men or women of childbearing potential who are unwilling to employ adequate
             contraception

          -  No inadequately treated gastrointestinal bleeding

          -  No ≥ grade 2 pre-existing peripheral sensory or motor neuropathy

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or lobular carcinoma in
             situ in 1 breast

          -  No other concurrent medical condition that would preclude study participation

          -  No concurrent biologic therapy

          -  No prior chemotherapy for colon cancer

          -  No other concurrent chemotherapy

          -  No prior radiotherapy for colon cancer

          -  No concurrent targeted agents

          -  No prior agents directed against epidermal growth factor-receptor

          -  No other concurrent anticancer therapy