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A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Refractory, EGFR-Negative Metastatic Colorectal Carcinoma

Phase 2
18 Years
Not Enrolling
Colorectal Neoplasms, Metastases, Neoplasm

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Trial Information

A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Refractory, EGFR-Negative Metastatic Colorectal Carcinoma

Inclusion Criteria:

- Provided signed written informed consent.

- Histologically- or pathologically- confirmed metastatic colorectal carcinoma;

- Documented PD after treatment with at least one standard chemotherapy regimen for
metastatic colorectal carcinoma;

- The chemotherapy regimen on which the patient progressed, must have included a

- Bidimensionally measurable disease;

- Immunohistochemical evidence of an absence of EGFR expression, (ie, EGFR-negative).
Patients who do not have tumor tissue available for EGFR testing will undergo biopsy
of accessible tumor. A reference laboratory designated by ImClone will perform the
EGFR assay.

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at study

- Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least
30 days must have elapsed from major surgery, prior chemotherapy, prior treatment
with an investigational agent or medical device, or prior radiation therapy;

- Accessible for treatment and follow-up. Patients enrolled in this trial must be
treated at the participating center.

- Men and women, 18 years of age and older

Exclusion Criteria:

- Women of child bearing potential (WOCBP) who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and for up to 4
weeks after the study.

- Women who are pregnant or breastfeeding.

- Women with a positive pregnancy test on enrollment or prior to cetuximab

- Sexually active fertile men not using effective birth control.

- Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent;

- A serious uncontrolled medical disorder that would impair the ability of the patient
to receive protocol therapy;

- A history of uncontrolled angina, arrhythmias or congestive heart failure;

- Symptomatic or uncontrolled metastases to the central nervous system. Patients
receiving a glucocorticoid for central nervous system (CNS) metastases will be
excluded, but those receiving anticonvulsants will be eligible.

- Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of
the cervix. Patients with a previous malignancy but without evidence of disease for
greater than or equal to 5 years will be allowed to enter the trial;

- Inadequate hematologic function defined by an absolute neutrophil count (ANC) less
than 1,500/mm3 , a platelet count less than 100,000/mm3 , or a hemoglobin level less
than 9 g/dL.

- Inadequate hepatic function, defined by a total bilirubin level greater than or equal
to 1.5 times the upper limit of normal (ULN) and aspartate transaminase (AST) or
alanine transaminase (ALT) levels greater than or equal to 5.0 times the ULN.

- Inadequate renal function defined by a serum creatinine level greater than 1.5 times
the ULN.

- Prior cetuximab or other therapy, which specifically and directly targets the EGF

- Prior hypersensitivity reaction to chimerized or murine monoclonal antibody therapy.

- Any chemotherapy not indicated in the study protocol, radiation therapy, hormonal
therapy (except for physiological replacement), or any other investigational agent.

- Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (eg, infectious disease) illness.

- Employees of the investigator or study center with direct involvement in this study
or other studies under the direction of the investigator or study center, as well as
family members of the employees.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With an Overall Resonse

Outcome Description:

Determine the response rate (complete response [CR] and partial response [PR]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the World Health Organization (WHO) criteria. The calculation was the total number of patients with CR or PR divided by the total number of patients treated.

Outcome Time Frame:

Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

April 2008

Related Keywords:

  • Colorectal Neoplasms
  • Metastases
  • Neoplasm
  • EGFR-undetectable
  • Metastatic Colorectal Cancer
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis



ImClone Investigational Site Indianapolis, Indiana  46202
ImClone Investigational Site New York, New York  10021
ImClone Investigational Site St. Charles, Missouri  63301
ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Jacksonville, Florida  32207
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site Louisville, Kentucky  40202
ImClone Investigational Site New Orleans, Louisiana  70121
ImClone Investigational Site Ypsilanti, Michigan  48198
ImClone Investigational Site Dallas, Texas  75230
ImClone Investigational Site Winston-Salem, North Carolina  27103
ImClone Investigational Site Philadelphia, Pennsylvania  19107
ImClone Investigational Site Boston, Massachusetts  02135