Exploratory Study Of The ERCC-1 Gene

Not Applicable

Completed

Brief Summary: This study is for patients with advanced or stage II and III colon or rectal cancer. The primary purpose of this research study is to determine if a particular protein in the patient's blood will change when they receive treatment with a drug called oxaliplatin, which is used to treat the colon or rectal cancer. This protein is called ERCC-1. It is thought that the amount of this protein in the blood could influence the manner in which the patient responds to oxaliplatin.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Resected or metastatic CRC	Oxaliplatin	All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin

Primary Outcome Measures

Name	Time	Method
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin	Change over 1 treatment cycle, up to 4 weeks	ERCC was measured at the expression level, by RT-PCR and Western Blotting from peripheral blood mononuclear cells

Secondary Outcome Measures

Name	Time	Method
Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level	Change over 1 treatment cycle, up to 4 weeks

Locations (2): Montefiore Medical Center - Weiler Campus
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Bronx, New York, United States
Montefiore Medical Center - Moses Campus
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Bronx, New York, United States