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Cetuximab in Treating Patients With Stage IV Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020930
  Purpose

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 Intervention Phase
Colorectal Cancer
Biological: cetuximab
Phase II

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020930

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Leonard B. Saltz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068731, MSKCC-01034, IMCL-CP02-0141, NCI-G01-1970
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00020930     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Cetuximab
Irinotecan
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Carcinoma
Antibodies
Digestive System Diseases
Rectal Cancer
Mitogens
Gastrointestinal Neoplasms
Colorectal Neoplasms
Immunoglobulins

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Cetuximab
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009