NCTN: A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer (N0147)

Study ID: N0147NCT Number: NCT00079274Trial Title: NCTN: A Randomized Phase III Trial of Oxaliplatin (OXAL) plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer (N0147)Alliance for Clinical Trials in OncologySubmitted in collaboration with the NCTN/NCORP Data ArchiveTrial Description: This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication.Clinical Data presented in the following publication(s): PMID 22474202Disease type(s): Gastrointestinal Neoplasm - Colorectal CancerClinical Dataset(s) included:NCT00079274-D1 (PMID 22474202): The NCT00079274_D1.txt dataset is one of 3 datasets associated with PubMed ID 22474202. This dataset contains information on baseline characteristics (e.g., age, race, etc.), eligibility (e.g. tumor staging, etc.), follow-up status (e.g., reason treatment ended, days from randomization until last protocol therapy, etc.), response status, and KRAS status.NCT00079274-D2 (PMID 22474202): The NCT00079274_D2.txt dataset is one of 3 datasets associated with PubMed ID 22474202. This dataset contains information on overall survival, disease free survival and time to recurrence analyses.NCT00079274-D3 (PMID 22474202): The NCT00079274_D3.txt dataset is one of 3 datasets associated with PubMed ID 22474202. This dataset contains information on grade 3 or higher reported toxicity.Additional genomic data are available for this trial under phs001290.]]>
NCT00079274 D1 Data DictionaryNCT00079274 D2 Data DictionaryNCT00079274 D3 Data DictionaryInclusion Criteria:Histologically confirmed adenocarcinoma of the colonStage III diseaseNo resected stage IV diseaseNo rectal cancerGross inferior (caudad) margin of the primary tumor must be ≥ 12 cm from the anal verge by rigid proctoscopyStage III tumor must have been completely resected within the past 56 daysMust have documented en bloc resection in patients with tumor adherence to adjacent structuresTumor-related obstructions and colonic perforation are allowedTumor samples must be availableAt least 1 pathologically confirmed positive lymph nodeNo evidence of residual involved lymph node diseaseSynchronous primary colon cancer allowedNo distant metastatic diseasePerformance status - Eastern Cooperative Oncology Group (ECOG) 0-2Absolute neutrophil count ≥ 1,500/mm^3Platelet count ≥ 100,000/mm^3Hemoglobin ≥ 9 g/dLBilirubin ≤ 1.5 times upper limit of normal (ULN)Creatinine ≤ 1.5 times ULNNo uncontrolled high blood pressureNo unstable anginaNo symptomatic congestive heart failureNo myocardial infarction with the past 6 monthsNo New York Heart Association class III or IV heart diseaseNo symptomatic pulmonary fibrosisNo symptomatic interstitial pneumonitisNo prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapyNo known allergy to platinum compoundsNo documented presence of human anti-mouse antibodies (HAMA)No active uncontrolled bacterial, viral, or systemic fungal infectionHIV negativeNo clinically defined AIDSNot pregnant or nursingNegative pregnancy testNo men or women of childbearing potential who are unwilling to employ adequate contraceptionNo inadequately treated gastrointestinal bleedingNo ≥ grade 2 pre-existing peripheral sensory or motor neuropathyNo 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 breastNo other concurrent medical condition that would preclude study participationNo concurrent biologic therapyNo prior chemotherapy for colon cancerNo other concurrent chemotherapyNo prior radiotherapy for colon cancerNo concurrent targeted agentsNo prior agents directed against epidermal growth factor-receptorNo other concurrent anticancer therapy]]>