Exploratory Study Of The ERCC-1 Gene

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00846482
Recruitment Status : Unknown
Verified February 2009 by Montefiore Medical Center.
Recruitment status was:  Recruiting
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
Information provided by:
Montefiore Medical Center

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.

Condition or disease Intervention/treatment
Colon Cancer Rectal Cancer Drug: Oxaliplatin

Study Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer
Study Start Date : February 2008
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Group/Cohort Intervention/treatment
All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin
Drug: Oxaliplatin
Oxaliplatin will be administered once every 2 or 3 weeks
Other Name: Eloxatin

Primary Outcome Measures :
  1. To see of the level of the ERCC protein will change in patients treated with oxaliplatin [ Time Frame: Change over 1 treatment cycle ]

Secondary Outcome Measures :
  1. Determine extent of ERCC polymorphism and its relationship to change in its level [ Time Frame: Over 1 cycle ]

Biospecimen Retention:   Samples With DNA
Biospecimens include blood and tumor samples.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Metastatic colon or rectal cancer

Stage II or III colon or rectal cancer


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846482

Contact: SANJAY GOEL, M.D. 718-904-2488
Contact: JOHN MARIADASON, Ph.D. 718-920-2025

United States, New York
Montefiore Medical Center - Weiler Campus Recruiting
Bronx, New York, United States, 10461
Contact: SANJAY GOEL, M.D.    718-904-2488   
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467
Contact: SANJAY GOEL, M.D.    718-920-4826   
Contact: JOHN MARIADASON, Ph.D.    718-920-2025   
Sponsors and Collaborators
Montefiore Medical Center

Responsible Party: SANJAY GOEL, M.D., MONTEFIORE MEDICAL CENTER Identifier: NCT00846482     History of Changes
Other Study ID Numbers: 07-10-376
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009

Keywords provided by Montefiore Medical Center:
Colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents