Exploratory Study Of The ERCC-1 Gene

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Montefiore Medical Center
• Collaborator: Sanofi
• Treatments: Oxaliplatin

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.