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Cetuximab in Treating Patients With Stage IV Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00020930
Recruitment Status : Completed
First Posted : March 17, 2004
Last Update Posted : December 4, 2009
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: cetuximab Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Patients With Irinotecan-Refractory, Stage IV Colorectal Carcinoma
Study Start Date : March 2001
Actual Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020930


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Leonard B. Saltz, MD Memorial Sloan Kettering Cancer Center
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ClinicalTrials.gov Identifier: NCT00020930    
Other Study ID Numbers: CDR0000068731
MSKCC-01034
IMCL-CP02-0141
NCI-G01-1970
First Posted: March 17, 2004    Key Record Dates
Last Update Posted: December 4, 2009
Last Verified: December 2009
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents