Colon CancerNCT00846482
Exploratory Study Of The ERCC-1 Gene
A study testing Oxaliplatin in people with Colon Cancer and Rectal Cancer, run by Albert Einstein College of Medicine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Montefiore Medical Center - Weiler Campus
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
About this study
Official title: Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer
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
- Being tested
- Oxaliplatin
- Keywords
- Colorectal cancer, Oxaliplatin, ERCC-1
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Eloxatin
Oxaliplatin will be administered once every 2 or 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Resected or metastatic CRC | Experimental | All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change over 1 treatment cycle, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Sanjay Goel, Albert Einstein College of Medicine
- Investigators
- SANJAY GOEL, M.D., Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846482
- Sponsor's protocol ID
- 07-10-376
- Status last verified
- Aug 2020
- First submitted
- 21 Feb 2008
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00846482
- Acronym / sponsor ID
- 07-10-376
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Colorectal cancer, Oxaliplatin, ERCC-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2008
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resected or metastatic CRC | Experimental | Drug: OxaliplatinAll patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinAlso: EloxatinOxaliplatin will be administered once every 2 or 3 weeks | Drug | Resected or metastatic CRC |
Primary outcome
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin
Time frame: Change over 1 treatment cycle, up to 4 weeks
ERCC was measured at the expression level, by RT-PCR and Western Blotting from peripheral blood mononuclear cells
1 secondary outcome
Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level
Time frame: Change over 1 treatment cycle, up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31565185Rao 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.
Related trials for Colon Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SANJAY GOEL, M.D. principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxaliplatin in people with Colon Cancer and Rectal Cancer, run by Albert Einstein College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin (time frame: Change over 1 treatment cycle, up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00846482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.