Colon Cancer, Rectal Cancer
Conditions
Keywords
Colorectal cancer, Oxaliplatin, ERCC-1
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.
Interventions
DRUGOxaliplatin
Oxaliplatin will be administered once every 2 or 3 weeks
Sponsors
Sanofi
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin | Change over 1 treatment cycle, up to 4 weeks | ERCC was measured at the expression level, by RT-PCR and Western Blotting from peripheral blood mononuclear cells |
Secondary
| Measure | Time frame |
|---|---|
| Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level | Change over 1 treatment cycle, up to 4 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Resected or Metastatic CRC All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin
Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Resected or Metastatic CRC |
|---|---|
| Age, Continuous | 59 years |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 14 Participants |
| Race/Ethnicity, Customized Hispanic | 26 Participants |
| Race/Ethnicity, Customized Unkown | 2 Participants |
| Race/Ethnicity, Customized White | 10 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
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
Time frame: Change over 1 treatment cycle, up to 4 weeks
Population: Any patient with CRC who received oxaliplatin
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients With CRC | Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin | 25 Participants |
Secondary
Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level
Time frame: Change over 1 treatment cycle, up to 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients With CRC | Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level | C/T genotype | 21 participants |
| All Patients With CRC | Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level | CC genotype | 22 participants |
| All Patients With CRC | Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level | TT genotype | 7 participants |