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Edrecolomab in Treating Patients With Stage II Colon Cancer

NCT00002968 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2100

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Mucinous Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Colon
  • Stage IIA Colon Cancer
  • Stage IIB Colon Cancer
  • Stage IIC Colon Cancer

Interventions

BIOLOGICAL

edrecolomab

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Thomas Colacchio · Cancer and Leukemia Group B

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Primary Completion
2003-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002968 on ClinicalTrials.gov