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

Phase 3
18 Years
Not Enrolling
Mucinous Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Colon, Stage IIA Colon Cancer, Stage IIB Colon Cancer, Stage IIC Colon Cancer

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Trial Information

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


I. To determine whether adjuvant treatment with MoAb 17-1A will improve the probability of
overall and disease-free survival, and increase disease-free intervals in patients who have
undergone resection of a Stage II colon cancer.

II. To determine whether alterations in the expression of cell cycle related genes
(thymidylate synthase, p53, and the cyclin-dependent kinase inhibitors p21 and p27) predict
the risk of survival and recurrence in this patient population.

III. To determine whether alterations in markers of metastatic potential-expression of DCC
and measures of tumor angiogenesis (microvascular density and vascular endothelial growth
factor expression)-predict the risk of survival and recurrence in this patient population.

IV. To determine whether a marker of cellular differentiation-sucrase isomaltase-predicts
the risk of survival and recurrence in this patient population.

V. To determine whether DNA ploidy and cell proliferation are prognostic of tumor recurrence
and overall survival in Stage II colon cancer.

VI. To determine whether interactions among these tumor markers identify subsets of patients
with significantly altered outcome.

VII. To determine whether pathologic features including tumor grade; tumor mitotic
(proliferation) index; tumor border configuration; host lymphoid response to tumor; and
lymphatic vessel, venous vessel and perineural invasion predict outcome in this patient

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 post-surgical resection. Patients also undergo observation at 3 and 6 months

Arm II: Patients undergo observation at 3 and 6 months post-randomization.

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.

Inclusion Criteria:

- Pathologic documentation of adenocarcinoma of the colon with or without penetration
of the serosa with no lymph node metastases (Stage II pT3N0 or pT4bNO lesions,
excluding pT4aN0; Modified Astler-Coller Stage B2); there can be no distant
metastases or penetration of adjacent organs or structures; proximal, distal, and
radial margins must be free of tumor Important note: A tumor nodule > 3 mm in
diameter in the perirectal or pericolonic adipose tissue without histologic evidence
of residual node in the nodule is classified as regional/pericolonic node metastasis;
however, a tumor nodule =< 3 mm in diameter is classified in the T category as
discontinuous extension (i.e., pT3); multiple metastatic foci seen microscopically
only in the pericolonic fat should be considered as metastasis in a single lymph node
for classification; although six or more nodes evaluated from the specimen is
optimal, a minimum of three nodes (periodic or mesenteric) for evaluation is required
for inclusion in the study

- Complete, en bloc resection of all the primary tumor, performed as an open procedure,
and not laparoscopically or laparoscopically assisted

- No evidence of perforation or clinical obstruction of the bowel

- The gross distal margin of the primary tumor must lie above the peritoneal reflection
(i.e., it must be a colon, not a rectal cancer)

- No previous radiation or chemotherapy for this malignancy

- CALGB Performance status 0-1

- No concurrent treatment with systemic steroids is allowed; patients receiving
replacement steroids for adrenal insufficiency are eligible; patients receiving
inhaled steroids in daily doses of 500mg or less and patients being treated with
topical steroids are eligible

- No prior exposure to murine antibodies (e.g., diagnostic tests like the "oncoscint

- No uncontrolled or severe cardiovascular disease

- No history of pancreatitis

- Non-pregnant and non-lactating; patients of child-bearing potential should agree to
use an effective method of birth control

- No previous or concurrent malignancy is allowed, except inactive non-melanoma skin
cancer, in situ carcinoma of the cervix, or other cancer if the patient has been
disease-free for >= 5 years; patients with more than one synchronous primary colon
tumor are eligible; for the purpose of this protocol, staging classification will be
based on the stage of the more advanced primary tumor

- Granulocytes > 1,800/μl

- Platelet count > 100,000/μl

- BUN < 1.5 x normal

- Creatinine < 1.5 x normal

- Bilirubin < 1.5 x normal

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Estimated using the Kaplan-Meier method. Compared using the logrank test.

Outcome Time Frame:

From time of randomization to death from any cause, assessed up to 5 years

Safety Issue:


Principal Investigator

Thomas Colacchio

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

May 1997

Completion Date:

Related Keywords:

  • Mucinous Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Colon
  • Stage IIA Colon Cancer
  • Stage IIB Colon Cancer
  • Stage IIC Colon Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Cystadenocarcinoma



Cancer and Leukemia Group B Chicago, Illinois  60606