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Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer


N/A
N/A
N/A
Open (Enrolling)
Both
Colon Cancer, Rectal Cancer

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Trial Information

Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

To see of the level of the ERCC protein will change in patients treated with oxaliplatin

Outcome Time Frame:

Change over 1 treatment cycle

Safety Issue:

No

Principal Investigator

SANJAY GOEL, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

MONTEFIORE MEDICAL CENTER, ALBERT EINSTEIN COLLEGE OF MEDICINE

Authority:

United States: Institutional Review Board

Study ID:

07-10-376

NCT ID:

NCT00846482

Start Date:

February 2008

Completion Date:

August 2010

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • Colorectal cancer
  • Oxaliplatin
  • ERCC-1
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Montefiore Medical Center - Moses CampusBronx, New York  10467
Montefiore Medical Center - Weiler CampusBronx, New York  10461