Current Clinical Trials at UIHC: GI Oncology Protocols: Dukes B3 and C Colorectal Ca.
James R. Howe, M.D.
Peer Review Status: Internally Peer
Reviewed
Objective:
Moertel demonstrated a significant survival benefit of 5-FU/Levamisole in a study of 1200 Dukes B2 and C colon cancer patients, versus levamisole, versus observation (this decreased cancer related deaths by 32%, p<0.004; NEJM 322:352, 1990). A previous study had shown that the benefit was seen in Dukes C but not B2 patients (J. Clin. Oncol. 7:1407, 1989). The mechanism of action of Levamisole is not known, but it is thought to increase chemotaxis of monocytes, restoring defective neutrophils, and perhaps causing release of lymphokines.
A study from Australia compared perioperative 5-FU given by portal infusion, versus systemic 5-FU, versus observation in 372 pts. Although in early follow-up it appears that there may be a survival advantage for portal infusion, it also showed that perioperative 5-FU systemically was well tolerated (Adj. Therapy of Cancer V. Grune and Stratton, 537-546, 1987).
Therefore, pts. will receive 600 mg/m2/d x 7 days postoperatively, followed by standard 5-FU levamisole. The control group will get standard 5-FU/Levamisole only.
2000 pts. will need to be accrued, and 327 have been entered over 25 months).
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