NCT00002968

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,100

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

6.2 years

First QC Date

November 1, 1999

Last Update Submit

December 26, 2025

Conditions

Signet Ring Adenocarcinoma of the ColonMucinous Adenocarcinoma of the ColonStage IIA Colon CancerStage IIB Colon CancerStage IIC Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Survival

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

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

Secondary Outcomes (2)

  • Disease-free intervals

    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

  • Disease-free survival

    From time of randomization to colon cancer recurrence or death from any cause, assessed up to 5 years

Study Arms (2)

Arm I (edrecolomab)

EXPERIMENTAL

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.

Biological: edrecolomabOther: laboratory biomarker analysis

Arm II (no treatment)

NO INTERVENTION

Patients undergo observation at 3 and 6 months postrandomization. .

Interventions

edrecolomabBIOLOGICAL

Given IV

Also known as: MOAB 17-1A, monoclonal antibody 17-1A, Panorex
Arm I (edrecolomab)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (edrecolomab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 scan")
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

Related Links

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

EdrecolomabRadiography, Panoramic

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Radiography, DentalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnosis, OralDentistry

Study Officials

  • Thomas Colacchio

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1997

Primary Completion

July 1, 2003

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations

US(1)