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CompletedNCT00846482Updated Sep 16, 2020Results posted

Exploratory Study Of The ERCC-1 Gene

An interventional study of Oxaliplatin in Colon Cancer and Rectal Cancer, sponsored by Albert Einstein College of Medicine. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Sex
All
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Study 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.

02

Conditions studied

  • Colon Cancer
  • Rectal Cancer

Keywords

  • Colorectal cancer
  • Oxaliplatin
  • ERCC-1
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 64 is close to the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Albert Einstein College of Medicine is the lead sponsor of 199 studies on the registry; 21 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 35 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Resected or metastatic CRC

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

    Drug: Oxaliplatin

Interventions

  • DrugOxaliplatin

    Oxaliplatin will be administered once every 2 or 3 weeks

    Also known as: Eloxatin

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What researchers measure

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

    Time frame: 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

    Time frame: Change over 1 treatment cycle, up to 4 weeks

07

Results

Posted Sep 16, 2020

Participant flow

Participant flow — Overall Study
MilestoneResected or Metastatic CRC
Started64
Completed54
Not completed10

Outcome measures

PrimaryNumber 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

Time frame:
Change over 1 treatment cycle, up to 4 weeks
Reported as:
Count of participants · Participants
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin
ParticipantsAll Patients With CRC
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin25
SecondaryDetermine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level
Time frame:
Change over 1 treatment cycle, up to 4 weeks
Reported as:
Number · participants
Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level
participantsResected or Metastatic CRC
CC genotype22
C/T genotype21
TT genotype7

Adverse events

Collected over 15 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Resected or Metastatic CRC0/54 (0%)0/54 (0%)0/54 (0%)

Baseline characteristics

Fifty-four patients consented to the study and underwent serial blood sampling. Blood samples were collected from every patient for at least at two of the four prespecified time points.

Age, Continuous
Age, Continuous(years)Resected or Metastatic CRC
Median59 (45 to 67)
Sex: Female, Male
Sex: Female, Male(Participants)Resected or Metastatic CRC
Female28
Male26
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Resected or Metastatic CRC
White10
Black14
Hispanic26
Asian2
Unkown2
08

Study locations

2 sites
  • Montefiore Medical Center - Weiler Campus
    Bronx, New York 10461, United States
  • Montefiore Medical Center - Moses Campus
    Bronx, New York 10467, United States
09

References and documents

Publications

  • 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. PubMed 31565185 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 4, 2015
  • Informed consent form · Jul 11, 2018

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00846482
Lead sponsor
Albert Einstein College of Medicine
Collaborators
Sanofi
Responsible party
Sanjay Goel (Sanjay Goel, MD, Albert Einstein College of Medicine) — Principal investigator
First posted
Feb 18, 2009
Start date
Feb 2008
Primary completion
Dec 2018
Completion
Dec 2018
Results posted
Sep 16, 2020
Last update
Sep 16, 2020

Study contacts

SANJAY GOEL, M.D.
principal investigator · Montefiore Medical Center/Albert Einstein College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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