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A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients

Phase 1
18 Years
90 Years
Not Enrolling
Colon Cancer

Thank you

Trial Information

A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients

Cetuximab's tumor growth inhibitory mechanism directly blocks EGFR. After binding to EGFR,
the antibody blocks signal transduction through the receptor with a subsequent inhibition of
tumor cell proliferation and MMP expression. We hypothesize that peri-operative weekly
administration of Cetuximab, a humanized monoclonal antibody to EGF receptor (EGFR), for 3
weeks immediately prior to surgery and for 3 weeks immediately after colon cancer surgery is
safe. This drug has been demonstrated to be effective in Stage 4 colon cancer patients and
is approved for use in colorectal cancer patients. Cetuximab has never been administered in
the month immediately before or after colon surgery. Establishing the safety of Cetuximab
in the perioperative setting is the primary objective of this study.

Inclusion Criteria:

- Patients must be between 18 and 85 years of age and have biopsy proven adenocarcinoma
of the large bowel at least 2 cm in size.

- Patients receiving preoperative study drug will not have undergone operation with
resection and pathologic staging and so will be Stage 1 or 2 or 3 patients. Patients
in groups who only receive postoperative study drug will be Stage 3 patients only.

- Patients may be of any race and either gender.

- Patients without evidence of Stage 4 cancer on the basis of preoperative chest
X-rays, abdominal and pelvic CT scans (preferably with IV and oral contrast), or
other metastatic work up (USG, PET, MRI) will be eligible for entry.

- Only those patients with colon tumors located between the proximal rectum (defined as
15 cm from the anal verge) and the cecum who are to undergo elective resection will
be eligible for this study.

- Those patients with a reasonable performance status (ECOG Performance Status Scale
score of O or 1) will be eligible for entry into the study.

- Those patients whose renal, hepatic, and hematologic blood test values meet the
following criteria will be eligible (as per the Columbia Presbyterian clinical
chemistry lab):

- Hemoglobin >8.0g/dL

- Neutrophils >1.5 x 10^9/L

- Lymphocytes >1.2 x 10^9/L

- Platelets >100 x 10^9/L

- Serum creatinine <1.8 mg/dL

- Serum bilirubin <2mg/dL

- SGOT <41mg/dL

- SGPT <41mg/dL

Exclusion Criteria:

- Patients with tumors less than 2 cm in size or those with polyp cancers that have
been fully removed or those who have had partial removal endoscopically where the
remnant is less than 2 cm in size are not eligible.

- Patients with a history of a second current malignancy or past malignancy (within the
past 5 years), other than the colon neoplasm in question (excepting basal cell skin
carcinomas) will not be eligible for entry into this study.

- Patients with rectal cancer (located between the anus and 15 cm proximal to the anal
verge) or Stage 4 colon cancer are not eligible.

- Patients with a history of immunosuppression secondary to a disease process, current
steroid usage, or the use of other immunosuppressive drugs, within three months of
the planned surgery, will not be eligible for this study.

- Patients with Hepatitis B or C or who are HIV positive will be excluded.

- Patients who have received chemotherapy or radiotherapy within 3 months of the
anticipated surgery will not be eligible.

- Patients with bowel obstruction, or other emergency indications for surgery, will not
be eligible.

- Pregnant or nursing patients are not eligible for entry into the study.

- All WOCBP must have a negative pregnancy test within 7 days prior to first
receiving investigational product. If the pregnancy test is positive, the
patient will not receive cetuximab and will not be eligible for entry into the

- In addition, all WOCBP will be instructed to contact the Investigator
immediately if they suspect they might be pregnant (e.g., missed or late
menstrual period) at any time during study participation.

- Prior to study enrollment, women of childbearing potential (WOCBP) must be
advised of the importance of avoiding pregnancy during trial participation and
the potential risk factors associated with an unintentional pregnancy in this
setting. In addition, men enrolled on this study should understand the risks to
any sexual partner of childbearing potential and should practice an effective
method of birth control.)

- The Investigator will immediately notify both the IRB and Bristol Meyers Squibb
in the event of a confirmed pregnancy in a patient participating in the study.

Type of Study:


Study Design:

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

Outcome Measure:

Safety of peri operative Cetuximab.

Outcome Time Frame:

within 90 days of surgery

Safety Issue:


Principal Investigator

Richard L Whelan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

November 2010

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms



St Luke's Roosevelt Medical Center New York, New York  10019