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
Information provided by:
Montefiore Medical Center
First received: February 21, 2008
Last updated: February 17, 2009
Last verified: February 2009
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.
||Time Perspective: Prospective
||Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer
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 ]
Biospecimen Retention: Samples With DNA
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 ]
Biospecimens include blood and tumor samples.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2010 (Final data collection date for primary outcome measure)
All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin
Oxaliplatin will be administered once every 2 or 3 weeks
Other Name: Eloxatin
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Metastatic colon or rectal cancer
Stage II or III colon or rectal cancer
- 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00846482
|Montefiore Medical Center - Moses Campus
|Bronx, New York, United States, 10467 |
|Contact: SANJAY GOEL, M.D. 718-920-4826 firstname.lastname@example.org |
|Contact: JOHN MARIADASON, Ph.D. 718-920-2025 email@example.com |
|Montefiore Medical Center - Weiler Campus
|Bronx, New York, United States, 10461 |
|Contact: SANJAY GOEL, M.D. 718-904-2488 firstname.lastname@example.org |
Montefiore Medical Center
||SANJAY GOEL, M.D.
||MONTEFIORE MEDICAL CENTER, ALBERT EINSTEIN COLLEGE OF MEDICINE
No publications provided
||SANJAY GOEL, M.D., MONTEFIORE MEDICAL CENTER
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 21, 2008
||February 17, 2009
||United States: Institutional Review Board
Keywords provided by Montefiore Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases