Clinical trial · Interventional
Exploratory Study Of The ERCC-1 Gene
Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Resected or metastatic CRC
- description
- All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin
- interventionNames
- Drug: Oxaliplatin
Primary outcomes (1)
- 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
- description
- ERCC was measured at the expression level, by RT-PCR and Western Blotting from peripheral blood mononuclear cells
Secondary outcomes (1)
- measure
- Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDRao 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