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Protocol B-51
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Protocol C-10
A Phase II Trial of 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) Chemotherapy Plus Bevacizumab for Patients with Unresectable Stage IV Colon Cancer and a Synchronous Asymptomatic Primary Tumor
Specific Aims
Primary Aim
To determine the rate of major morbidity for patients who are treated with mFOLFOX6 + bevacizumab without resection of the primary tumor. Major morbidity is defined as any event related to the intact primary tumor necessitating surgery or resulting in patient death.
Secondary Aim
Local Complications
To determine the rate of specific events related to the intact primary tumor requiring hospitalization or a major intervention but not requiring surgery.
Serious Adverse Events Related to Study Therapy
To determine the rate of ≥ grade 3 toxicity as defined by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) that is related to study therapy prior to disease progression.
To determine overall survival.