Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A vs. No Adjuvant Therapy Following Resection for Stage II (Modified Astler - Coller B2) Adenocarcinoma of the Colon.

Pathologic documentation of adenocarcinoma of the colon w/ or w/o penetration of the serosa w/ no lymph node mets (Stage II pT3N0 or PT4bN0 lesions, excluding pT4aN0; Modified Astler-Coller Stage B2); no distant mets or penetration of adjacent organs or structures; proximal, distal & radial margins must be free of tumor (see Section 3.2.1 of protocol for clarification). Complete en bloc resec of all primary tumor (performed as open procedure NOT laparoscopically or laparoscopically assisted); no evidence of perforation or clinical obstruc of bowel; gross distal margin of primary tumor must lie above the peritoneal reflection (i.e., must be colon, not rectal cancer); no previous RT or CT for this malig; CALGB PS 0-1; no concurrent treatment with systemic steroids (pts receiving replacement steroids for adrenal insufficiency or pts receiving inhaled steroids < 500 µg/day are eligible); no prior exposure to murine antibodies; no uncontrolled or severe cardiovascular dz; no history of pancreatitis; non-preg/non-lactating; no previous or concurrent malig; granulocytes > 1800/µl/PLT > 100,000/µl, BUN, Creat and Bili < 1.5 x NL..