Exploratory Study Of The ERCC-1 Gene

Metastatic colon or rectal cancer

Stage II or III colon or rectal cancer

Inclusion Criteria:

• Histologically confirmed diagnosis of colorectal cancer.
• ECOG Performance Status 0-2 (Appendix A).
• Patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting.
• Consent to donate 4 tubes of PBMC of 7 ml of blood each.
• Willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria).

• Adequate organ function as defined as:

  • Neutrophil count > 1500/μl
  • Platelets > 75,000/ μl
  • Hemoglobin > 8 g/dl
  • Bilirubin < 2.0 X upper limit of normal
  • Creatinine < 2 mg% or calculated clearance > 40 ml/mt
• The patient must have signed a consent form approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB

Exclusion Criteria:

• No other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment.
• Pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study.
• Patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery).
• Patients with grade 2 neuropathy will not be eligible for the study.
• The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas. At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.