Mucinous Adenocarcinoma of the Colon Clinical Trial
Official title:
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
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. 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.
PRIMARY OBJECTIVES:
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
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 post-surgical resection. Patients also undergo observation at 3 and 6 months
post-randomization.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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