Pilot Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Combination With Irinotecan, Fluorouracil, and Leucovorin, and in Patients With Newly Diagnosed Stage IV Colorectal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Pilot Study of an Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Combination With Irinotecan, Fluorouracil, and Leucovorin, and in Patients With Newly Diagnosed Stage IV Colorectal Carcinoma


OBJECTIVES: I. Determine the safety profile of cetuximab, irinotecan, leucovorin calcium,
and fluorouracil in patients with stage IV colorectal cancer. II. Determine the response
rate and time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours once
weekly on weeks 1-6. Patients also receive irinotecan IV over 90 minutes, leucovorin calcium
IV over 10-15 minutes, and fluorouracil IV over 3-5 minutes once weekly on weeks 1-4.
Treatment repeats every 6 weeks in the absence of disease progression or unacceptable
toxicity. Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage IV colorectal cancer Any T, any N,
M1 Immunohistochemical evidence of epidermal growth factor receptor expression (at least
1+) Bidimensionally measurable metastatic disease Meningeal or CNS involvement by tumor
allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least 1,500/mm3
Platelet count at least 150,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin normal
AST no greater than 5 times upper limit of normal (ULN) Renal: Creatinine no greater than
1.5 times ULN Cardiovascular: No history of uncontrolled angina, arrhythmias, or
congestive heart failure Neurologic: No uncontrolled seizure disorder No active
neurological disease No grade 2 or greater neuropathy Other: No other malignancy within
the past 3 years except basal cell skin cancer or pre-invasive carcinoma of the cervix 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 No
prior cetuximab Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant
chemotherapy for stage I, II, or III colorectal cancer allowed only if disease-free for
more than 1 year from completion of therapy until the first evidence of metastatic disease
No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy for metastatic disease No concurrent radiotherapy Surgery: At least 3 weeks
since prior surgery (excluding prior diagnostic biopsy) Other: No prior treatment for
metastatic colorectal cancer At least 30 days since prior investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-037

NCT ID:

NCT00020917

Start Date:

February 2001

Completion Date:

February 2004

Related Keywords:

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

Name

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