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Exploratory Study Of The ERCC-1 Gene

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00846482
First received: February 21, 2008
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

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 Intervention
Colon Cancer
Rectal Cancer
Drug: Oxaliplatin

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • To see of the level of the ERCC protein will change in patients treated with oxaliplatin [ Time Frame: Change over 1 treatment cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine extent of ERCC polymorphism and its relationship to change in its level [ Time Frame: Over 1 cycle ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimens include blood and tumor samples.


Estimated Enrollment: 40
Study Start Date: February 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Metastatic colon or rectal cancer

Stage II or III colon or rectal cancer

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846482

Contacts
Contact: SANJAY GOEL, M.D. 718-904-2488 sgoel@montefiore.org
Contact: JOHN MARIADASON, Ph.D. 718-920-2025 jmariada@aecom.yu.edu

Locations
United States, New York
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467
Contact: SANJAY GOEL, M.D.    718-920-4826    sgoel@montefiore.org   
Contact: JOHN MARIADASON, Ph.D.    718-920-2025    jmariada@aecom.yu.edu   
Montefiore Medical Center - Weiler Campus Recruiting
Bronx, New York, United States, 10461
Contact: SANJAY GOEL, M.D.    718-904-2488    sgoel@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Sanofi
Investigators
Principal Investigator: SANJAY GOEL, M.D. MONTEFIORE MEDICAL CENTER, ALBERT EINSTEIN COLLEGE OF MEDICINE
  More Information

No publications provided

Responsible Party: SANJAY GOEL, M.D., MONTEFIORE MEDICAL CENTER
ClinicalTrials.gov Identifier: NCT00846482     History of Changes
Other Study ID Numbers: 07-10-376
Study First Received: February 21, 2008
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Colorectal cancer
Oxaliplatin
ERCC-1

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014