Exploratory Study Of The ERCC-1 Gene

NCT00846482 | Completed Results DMC

• 1 other identifier: 07-10-376
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Colorectal cancer; Oxaliplatin; ERCC-1

Outcome Measures

Primary Outcomes (1)

• 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

  Change over 1 treatment cycle, up to 4 weeks

Secondary Outcomes (1)

• Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level

  Change over 1 treatment cycle, up to 4 weeks

Study Arms (1)

Resected or metastatic CRC

EXPERIMENTAL

All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin

Drug: Oxaliplatin

Interventions

Oxaliplatin DRUG

Oxaliplatin will be administered once every 2 or 3 weeks

Also known as: Eloxatin

Resected or metastatic CRC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Sanofi: collaborator

Study Sites (2)

Montefiore Medical Center - Weiler Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 31565185 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Dr. Sanjay Goel
• Organization: Montefiore Medical Center

sgoel@montefiore.org

718-405-8404

Study Officials

• SANJAY GOEL, M.D.

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sanjay Goel, MD

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 18, 2009
• Study Start: February 1, 2008
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Locations

US (2)