Exploratory Study Of The ERCC-1 Gene

NCT ID: NCT00846482

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE

Study Groups

Resected or metastatic CRC

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

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin will be administered once every 2 or 3 weeks

Interventions

Oxaliplatin

Oxaliplatin will be administered once every 2 or 3 weeks

Intervention Type: DRUG

Other Intervention Names

Eloxatin

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.

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

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Sanjay Goel

Sanjay Goel, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SANJAY GOEL, M.D.

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

Montefiore Medical Center - Weiler Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31565185 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

07-10-376

Identifier Type: -

Identifier Source: org_study_id