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A Phase II Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Neoplasms

Thank you

Trial Information

A Phase II Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer

Inclusion Criteria:

- Subjects must have signed an approved informed consent prior to any study procedures.

- Subjects with histologically or pathologically confirmed metastatic colorectal
cancer, which is EGFR-positive by IHC (may be based on archival samples)

- Subjects with ECOG performance status 0, 1 or 2.

- Subjects who have failed, either due to lack of efficacy or due to intolerance, all
available chemotherapy for the treatment of metastatic colorectal cancer.

- Subjects who have failed to meet eligibility criteria for any other existing
cetuximab trial.

- Subjects must have received at least two chemotherapy regimens for metastatic disease
OR adjuvant therapy plus one chemotherapy regimen for metastatic disease, provided
the subject progressed within 6 months of completing their adjuvant therapy.

- Prior chemotherapy must have included all of the follow drugs: irinotecan,
oxaliplatin, and a fluoropyrimidine.

- Subjects adequately recovered from any recent surgery, radiation therapy or

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

- Subjects greater or equal to 18 years of age.

- Women of childbearing potential must be using an adequate method of contraception to
avoid pregnancy throughout the study and for up to 4 weeks afterwards.

Exclusion Criteria:

- Women of childbearing potential 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

- Women who are pregnant or breastfeeding.

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

- Sexually active, fertile men not using adequate birth control.

- Subjects with dementia, altered mental status, or any psychiatric condition that
would prohibit the understanding or rendering of informed consent.

- Subjects with a serious uncontrolled medical disorder that would impair the ability
of the patient to receive protocol therapy.

- Subjects with a history of uncontrolled angina, arrhythmias, congestive heart
failure, or myocardial infarction within the previous 6 months.

- Subjects with any concurrent malignancy other than non-melanoma skin cancer, or
carcinoma in situ of the cervix. Subjects with a previous malignancy but without
evidence of disease for > 5 years will be allowed to enter the trial.

- Subjects with any history of severe hypersensitivity reactions and/or anaphylaxis
resulting from the administration of protein based therapeutic agents.

- Subjects with inadequate hematologic function defined by an absolute neutrophil count
(ANC) <1,250/mm3, a platelet count <75,000/mm3, and a hemoglobin level <8 g/dL.

- Subjects with inadequate hepatic function, defined by a total bilirubin level ³3
times the upper limit of normal (ULN) and an aspartate transaminase (AST) and alanine
transaminase (ALT) levels >5 x ULN.

- Subjects with inadequate renal function defined by a serum creatinine level >2.5 x

- Prior cetuximab therapy, prior randomization on a study which includes cetuximab
therapy in a treatment arm, or any other prior therapy that targets the EGFR pathway.

- A history of prior therapy with a chimerized or murine monoclonal antibody.

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study.

- A history of cetuximab or therapy that targeted the EGFR receptor.

- A history of prior anti-cancer murine monoclonal antibody therapy.

- Additional concurrent chemotherapy or other investigational anticancer agents may not
be administered to subjects on this study.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The objective of this study will be to monitor the safety of administering cetuximab,via an access program, to subjects with metastatic colorectal carcinoma who have exhausted all standard therapies or treatment options.

Outcome Time Frame:

Every 4 weeks untill disease progression

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:

February 2003

Completion Date:

August 2004

Related Keywords:

  • Colorectal Neoplasms
  • Stage IV colorectal cancer
  • Neoplasms
  • Colorectal Neoplasms



ImClone Investigational Site Denver, Colorado  80262
ImClone Investigational Site Greenwich, Connecticut  06830
ImClone Investigational Site New York, New York  10021
ImClone Investigational Site St. Charles, Missouri  63301
ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Washington, District of Columbia  20057
ImClone Investigational Site Jacksonville, Florida  32207
ImClone Investigational Site Atlanta, Georgia  30318
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site Louisville, Kentucky  40202
ImClone Investigational Site New Orleans, Louisiana  70121
ImClone Investigational Site Baltimore, Maryland  21204
ImClone Investigational Site Ypsilanti, Michigan  48198
ImClone Investigational Site Minneapolis, Minnesota  55416
ImClone Investigational Site Great Falls, Montana  59405
ImClone Investigational Site Las Vegas, Nevada  89109
ImClone Investigational Site Voorhees, New Jersey  08043
ImClone Investigational Site Cleveland, Ohio  44134
ImClone Investigational Site Portland, Oregon  97239
ImClone Investigational Site Greenville, South Carolina  29605
ImClone Investigational Site Memphis, Tennessee  38104
ImClone Investigational Site Dallas, Texas  75230
ImClone Investigational Site Norfolk, Virginia  23502
ImClone Investigational Site Green Bay, Wisconsin  54307