At a glance
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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
In Brief
A Phase 2 clinical trial evaluating bevacizumab, fluorouracil, and 2 other interventions for Colorectal Cancer. Completed, enrolled 90 participants across 163 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery.
Study Details
Timeline
Interventions
bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression
5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression
leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression
Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression