Clinical Research Directory

Inclusion Criteria: * Man or woman ≥ 18 years of age at the time the informed consent is obtained * ECOG performance status of 0-2 * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease * There should be at least 1 uni-dimensionally measurable (min. 10mm) using conventional crosssectional imaging techniques (CT or MRI scan). Lesion must not be chosen from a previously irradiated field, unlessnthere has been documented disease progression in that field after irradiation and prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization * Adequate hematology, renal, hepatic and coagulation function (at treating physician's discretion) * Adequate blood results for treatment (at treating physician's discretion) * Starting a first line treatment Exclusion Criteria: * History of prior or concurrent central nervous system metastases * History of other malignancy, except: Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer * Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) * Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer ≤ 6 months prior to randomization with the following exceptions: Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of rectal cancer. * Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities.