To determine if the addition of cetuximab to FOLFIRI (leucovorin, 5-FU, and irinotecan) or FOLFOX (leucovorin, 5-FU and oxaliplatin) chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer (CRC) who have K-ras wild type tumors.
To evaluate response, progression-free survival (PFS), time to treatment failure (TTF), and duration of response (DR) among patients with unresectable advanced metastatic CRC treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX.
To evaluate toxicity and, in particular, 60-day mortality among patients with unresectable advanced metastatic CRC treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX.
To describe patients with unresectable locally advanced or metastatic CRC cancer rendered "resectable" with chemotherapy.
To determine if there are significant differences in health-related quality of life among study patients by treatment arm (i.e. FOLFOX or FOLFIRI plus bevacizumab; FOLFOX or FOLFIRI plus cetuximab; FOLFOX or FOLFIRI plus bevacizumab and cetuximab).
To determine the degree to which patients enrolled in the clinical trial have access to prescription drug coverage to pay for the cost of supportive medication during chemotherapy and to identify the extent to which paying for costs of prescription medications is a source of hardship and worry for clinical trial participants.
To compare the effects of the different combinations of chemotherapy and biologic agents on resource utilization, cost, and utilities, and of applicable, to make estimates of marginal cost-utility.
To prospectively assess the influence of diet, obesity, physical activity, and other lifestyle habits on treatment-related toxicity, progression-free survival and overall survival in patients with stage IV CRC.
To perform correlative science studies in consenting patients.