• Disease-free intervals [ Designated as safety issue: No ]
• Disease-free survival [ Designated as safety issue: No ]

• Disease-free intervals
• Disease-free survival

RATIONALE: Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer.

OBJECTIVES:

• Determine whether adjuvant therapy with edrecolomab improves the probability of survival and disease-free survival and increases disease-free intervals in patients who have undergone resection for stage II colon cancer.
• Determine whether alterations in the expression cell cycle related genes predict the risk of survival or recurrence in this patient population.
• Determine whether alterations in markers of metastatic potential such as expression of the "Deleted in Colon Cancer" (DCC) gene, and measures of tumor angiogenesis predict the risk of survival and recurrence in these patients.
• Determine whether markers of cellular differentiation (e.g., sucrase isomaltase) predict the risk of survival or recurrence in these patients.
• Determine whether DNA ploidy and cell proliferation are prognostic of tumor recurrence and overall survival in stage II colon cancer.
• Determine whether interactions among these tumor markers identify subsets of patients with significantly altered outcomes.
• Determine whether pathologic features including tumor grade, tumor mitotic (proliferation) index, tumor border configuration, and host lymphoid response to tumor and lymphatic, venous, and perineural invasion predict outcome in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to degree of differentiation (well vs moderately well vs poor), vascular or lymphatic invasion (no vs yes), and preoperative serum CEA (less than 5.0 ng/mL vs at least 5.0 ng/mL vs unknown). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive adjuvant edrecolomab IV over 2 hours on day 1. Treatment repeats every 28 days for 5 courses. Patients must begin therapy no earlier than 7 days and no later than 42 days postsurgical resection. Patients also undergo observation at 3 and 6 months postrandomization.
• Arm II: Patients undergo observation at 3 and 6 months postrandomization. Patients are followed after the last course of edrecolomab (arm I) and at 12 months (arm II). All patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 2,100 patients will be accrued for this study within 4.7 years.

DISEASE CHARACTERISTICS:

• Histologically proven adenocarcinoma of the colon (Stage II pT3, N0 or pT4b, N0, excluding pT4a, N0)

  • With or without penetration of the serosa
  • No lymph node metastases
  • No distant metastases or penetration of adjacent structures/organs
  • Proximal, distal, and radial margins must be tumor free
  • A minimum of three (optimal of 6) nodes (pericolic or mesenteric) are required for evaluation

• Complete en bloc resection of all primary tumors (not performed or assisted by laparoscopic methods)

  • No evidence of perforation or obstruction of the bowel
• Must be a colon, not a rectal, cancer
• More than one synchronous primary colon tumor allowed

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance Status:

• CALGB 0-1

Life Expectancy:

• More than 2 years

Hematopoietic:

• Granulocyte count greater than 1,800/mm3
• Platelet count greater than 100,000/mm3

Hepatic:

• BUN less than 1.5 times normal
• Bilirubin less than 1.5 times normal

Renal:

• Creatinine less than 1.5 times normal

Cardiovascular:

• No uncontrolled or severe cardiovascular disease

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
• No psychosis
• No history of pancreatitis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior exposure to murine antibodies

Chemotherapy:

• No prior chemotherapy for adenocarcinoma of the colon
• No concurrent chemotherapy

Endocrine therapy:

• No concurrent systemic steroids
• No concurrent hormonal therapy except for non-disease-related conditions (e.g., insulin for diabetes)
• No concurrent corticosteroids, including replacement steroids for adrenal insufficiency
• Concurrent inhaled steroids in daily doses of 500 ug or less allowed
• Concurrent topical steroids allowed

Radiotherapy:

• No prior radiotherapy for adenocarcinoma of the colon

Surgery:

• See Disease Characteristics
• Recovered from prior surgery

• National Cancer Institute (NCI)
• Southwest Oncology Group
• Eastern Cooperative Oncology Group
• North Central Cancer Treatment Group
• European Organization for Research and Treatment of Cancer
• NCIC Clinical Trials Group