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Phase II Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Patients With Irinotecan-Refractory, Stage IV Colorectal Carcinoma

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Phase II Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Patients With Irinotecan-Refractory, Stage IV Colorectal Carcinoma

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.

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021