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

This is an interventional treatment trial for Colon Cancer Read More

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 study.
  • 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.