Trial Information
Summary: SWOG C80405: A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
You have been asked to participate in this research study because you have colon or rectal cancer that has spread and you have not received treatment for it. The purpose of this study is to determine if adding cetuximab to the standard chemotherapy treatments FOLFIRI (folinic acid (leucovorin), fluorouracil, irinotecan) or FOLFOX (folinic acid (leucovorin), fluorouracil, oxaliplatin) with or without bevacizumab helps to extend a subject’s life compared to FOLFIRI or FOLFOX with bevacizumab alone. Researchers will also evaluate how well and how long the cancer responds to the different treatments, the side effects they cause, and how they impact quality of life. The study will also identify characteristics of subjects able to continue to resection (surgical removal of the cancer) after treatment. Researchers will also evaluate the effect on subjects of paying for treatment and differences in additional healthcare required by the treatments. In addition, the study will evaluate the influence of diet, obesity, activity and lifestyle on side effects and survival. Your treatment on this study is expected to last as long as your tumor is not growing and your side effects are manageable. After you finish treatment, your medical condition will be followed indefinitely.
Patient Inclusion/Exclusion Criteria:
- See http://clinicaltrials.coh.org for additional information.
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Contact:
City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Telephone: 866-896-HOPE (4673)
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Trial listings updated: June 2, 2008 at 2:50:57 PM