Clinical Trial: Edrecolomab in Treating Patients With Stage II Colon Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 differentiatio
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Survival [ Time Frame: From time of randomization to death from any cause, assessed up to 5 years ]

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


Original Primary Outcome:

Current Secondary Outcome:

  • Disease-free intervals [ Time Frame: From time of randomization to colon cancer recurrence where deaths without recurrence will be censored at the time of death, assessed up to 5 years ]
    Estimated using the Kaplan-Meier method. Compared using the logrank test.
  • Disease-free survival [ Time Frame: From time of randomization to colon cancer recurrence or death from any cause, assessed up to 5 years ]
    Estimated using the Kaplan-Meier method. Compared using the logrank test.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 1, 1999
Date Started: May 1997
Date Completion:
Last Updated: June 4, 2013
Last Verified: June 2013