MedDataX Logo

Cetuximab in Treating Patients With Stage IV Colorectal Cancer

NCT ID: NCT00020930

Last Updated: 2009-12-04

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

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Brief Summary

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

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of cetuximab in treating patients who have stage IV colorectal cancer that has not responded to previous treatment.

Detailed Description

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

OBJECTIVES: I. Determine the response rate of patients with irinotecan-refractory, stage IV colorectal cancer when treated with cetuximab. II. Determine the safety and toxic effects of this drug in these patients. III. Determine the time to progression of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours weekly for 6 weeks. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 months.

Conditions

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

Colorectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer

Study Design

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

Primary Study Purpose

TREATMENT

Interventions

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

cetuximab

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent stage IV colorectal cancer Any T, any N, M1 Documented progressive disease within 6 months of completing an irinotecan- containing regimen Bidimensionally measurable metastatic disease Meningeal or CNS involvement allowed Immunohistochemical evidence of EGFR expression (at least 1+)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history of uncontrolled angina, arrhythmias, or congestive heart failure Other: No other malignancy within the past 3 years except basal cell skin cancer or pre-invasive carcinoma of the cervix No uncontrolled seizure disorder No neuropathy greater than grade 2 or other neurologic disease No medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy or cetuximab Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No other chemotherapy since completing irinotecan-containing regimen No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 30 days since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 21 days since prior surgery, except diagnostic biopsy, and recovered Other: At least 30 days since prior investigational agents and recovered
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

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

Leonard B. Saltz, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

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

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MSKCC-01034

Identifier Type: -

Identifier Source: secondary_id

IMCL-CP02-0141

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1970

Identifier Type: -

Identifier Source: secondary_id

CDR0000068731

Identifier Type: -

Identifier Source: org_study_id