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Colon Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage IV and Recurrent Colon Cancer Treatment

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Second-line chemotherapy

Second-line chemotherapy with irinotecan in patients treated with 5-FU-leucovorin as first-line therapy demonstrated improved OS when compared with either infusional 5-FU or supportive care.[74,75,76,77]

Similarly, a phase III trial randomly assigned patients who progressed on irinotecan and 5-FU-leucovorin to bolus and infusional 5-FU-leucovorin (LV5FU2), single-agent oxaliplatin, or FOLFOX4. The median TTP for FOLFOX4 versus LV5FU2 was 4.6 months versus 2.7 months (stratified log-rank test, 2-sided P < .001).[78][Level of evidence: 1iiDiii]

Third-line chemotherapy

Regorafenib is an inhibitor of multiple tyroisine kinase pathways including vascular endothelial growth factor (VEGF). In September 2012, the FDA granted approval for the use of regorafenib in patients who had progressed on prior therapy. The safety and effectiveness of regorafenib were evaluated in a single, clinical study of 760 patients with previously treated metastatic colorectal cancer.[79] Patients were randomly assigned to receive regorafenib or placebo in addition to best supportive care. Patients treated with regorafenib had a statistically significant improvement in OS (6.4 months vs. 5 months, HR, 0.493; 95% CI, 0.418–0.581; 1-sided P < .000001).[79]

Treatment Options Under Clinical Evaluation

Treatment options under clinical evaluation for stage IV and recurrent colon cancer include the following:

  1. Clinical trials evaluating new drugs and biological therapy.
  2. Clinical trials comparing various chemotherapy regimens or biological therapy, alone or in combination.

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage IV colon cancer and recurrent colon cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

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Last Updated: February 25, 2014
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