Clinical trial NCT00846482: Exploratory Study Of The ERCC-1 Gene
Official title: Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Keywords: Colorectal cancer
Oxaliplatin
ERCC-1
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2009-02-18
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin
timeFrame: Change over 1 treatment cycle, up to 4 weeks
Secondary outcomes:
measure: Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level
timeFrame: Change over 1 treatment cycle, up to 4 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center - Weiler Campus
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: SANJAY GOEL, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rao D, Mallick AB, Augustine T, Daroqui C, Jiffry J, Merla A, Chaudhary I, Seetharam R, Sood A, Gajavelli S, Aparo S, Rajdev L, Kaubisch A, Chuy J, Negassa A, Mariadason JM, Maitra R, Goel S. Excision repair cross-complementing group-1 (ERCC1) induction kinetics and polymorphism are markers of inferior outcome in patients with colorectal cancer treated with oxaliplatin. Oncotarget. 2019 Sep 17;10(53):5510-5522. doi: 10.18632/oncotarget.27140. eCollection 2019 Sep 17.