NCCTG NO147
| Principal Investigator: | Peter Kozuch, MD |
| Time frame of study: | Ongoing |
| Location of Study: | Beth Israel Medical Center |
| Contact: | Continuum Cancer Research Program |
Summary:
The chemotherapy regimen 5-fluorouracil/leucovorin and oxaliplatin has
been established as the current standard of care for adjuvant treatment
of colon cancer.
The antibody cetuximab is directed against the epidermal growth factor
receptor (EGFR), which is involved in the development and progression
of many common tumors including colon cancer. Cetuximab has demonstrated
a survival benefit in metastatic colon cancer (cancer that has spread
to other organs). This trial will compare the disease free survival benefit
and side effects of 5-fluorouracil and oxaliplatin with or without additional
cetuximab.
Eligibility and Treatment Plan:
Patients, 18 years and older, with histologically confirmed adenocarcinoma
of the colon (Stage III tumor completely resected), at least 1 pathologically
confirmed lymph node identified, and no residual lymph node disease.
There are two treatment arms: (one cycle of therapy is a 2-week treatment
period)
• Arm A) 12 cycles of oxaliplatin, 5-fluourouracil, and leucovorin,
• Arm D) 12 cycles of cetuximab + oxaliplatin, 5-fluourouracil,
and leucovorin. Treatment will be intravenous (through the vein).
Benefits and/or Compensation:
Participants receive study-related medication at no charge under the supervision
and care of a team of medical professionals. The information gathered
from this study may be beneficial to future patients, and cetuximab may
improve disease free and overall survival time for stage III colon cancer
patients.
Copyright © 2008