Exploratory Study Of The ERCC-1 Gene

Study Overview
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Brief Summary
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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.

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

Conditions
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Colon Cancer, Rectal Cancer

Intervention / Treatment
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* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resected or metastatic CRC<br>All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin | Drug: Oxaliplatin<br>* Oxaliplatin will be administered once every 2 or 3 weeks<br>* Other names: Eloxatin;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level |  | Change over 1 treatment cycle, up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Oxaliplatin, ERCC-1