Status:
COMPLETED
Exploratory Study Of The ERCC-1 Gene
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
Sanofi
Conditions:
Colon Cancer
Rectal Cancer
Eligibility:
All Genders
Phase:
NA
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 chan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00846482
Start Date
February 1 2008
End Date
December 1 2018
Last Update
September 16 2020
Active Locations (2)
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1
Montefiore Medical Center - Weiler Campus
The Bronx, New York, United States, 10461
2
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467