Edrecolomab in Treating Patients With Stage II Colon Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (edrecolomab)

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.

Group Type EXPERIMENTAL

edrecolomab

Intervention Type BIOLOGICAL

Given IV

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Arm II (no treatment)

Patients undergo observation at 3 and 6 months postrandomization. .

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

edrecolomab

Given IV

Intervention Type BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MOAB 17-1A monoclonal antibody 17-1A Panorex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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
* Bilirubin \< 1.5 x normal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Colacchio

Role: PRINCIPAL_INVESTIGATOR

Cancer and Leukemia Group B

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cancer and Leukemia Group B

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada United States