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Exploratory Study Of The ERCC-1 Gene

CompletedNA

Sponsor: Albert Einstein College of Medicine

Conditions: Colon Cancer, Rectal Cancer

Interventions: Oxaliplatin

Countries: United States

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (2)

The Bronx, New York, United States
The Bronx, New York, United States