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.
Brief Title
Exploratory Study Of The ERCC-1 Gene
Categories
Completion Date
Completion Date Type
Actual
Conditions
Colon Cancer
Rectal Cancer
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Colorectal cancer
Oxaliplatin
ERCC-1
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT00846482
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
07-10-376
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer
Primary Outcomes
Outcome Description
ERCC was measured at the expression level, by RT-PCR and Western Blotting from peripheral blood mononuclear cells
Outcome Measure
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin
Outcome Time Frame
Change over 1 treatment cycle, up to 4 weeks
Secondary Outcomes
Outcome Time Frame
Change over 1 treatment cycle, up to 4 weeks
Outcome Measure
Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sanjay Goel
Investigator Email
sgoel@montefiore.org
Investigator Phone
718-405-8404
Categories Mesh Debug
Gastrointestinal (GI) Cancers --- COLORECTAL NEOPLASMS
Gastrointestinal (GI) Cancers --- INTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- COLONIC DISEASES
Digestive System --- COLONIC DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
MeSH Terms
COLONIC NEOPLASMS
RECTAL NEOPLASMS
COLORECTAL NEOPLASMS
INTESTINAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
DIGESTIVE SYSTEM DISEASES
GASTROINTESTINAL DISEASES
COLONIC DISEASES
INTESTINAL DISEASES
RECTAL DISEASES
OXALIPLATIN
COORDINATION COMPLEXES
ORGANIC CHEMICALS