Exploratory Study Of The ERCC-1 Gene

Rectal Cancer Clinical Trial

Official title:

Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846482
• Other study ID #: 07-10-376
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: December 2018

Study information

• Verified date: August 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Oxaliplatin
Oxaliplatin will be administered once every 2 or 3 weeks

Locations

Country	Name	City	State
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Montefiore Medical Center - Weiler Campus	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Sanofi

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Change over 1 treatment cycle, up to 4 weeks
Secondary	Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level		Change over 1 treatment cycle, up to 4 weeks