Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal 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.