Know Cancer

forgot password

Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy

18 Years
Not Enrolling
Colonic Diseases, Cancer

Thank you

Trial Information

Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy

This is a single-arm, non-randomized trial of oxaliplatin and capecitabine. Patients that
are placed on other studies that utilize the same chemotherapy regimen can enter this study.
Those patients will be treated according to the clinical study on which they have been
entered. For patients not on another clinical trial, the treatment outlined below should be

Inclusion Criteria:

- All patients, >18 years of age, with metastatic/recurrent colorectal cancer are

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have a Zubrod performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of > 1,500 or cells/mm3 and platelet count > 100,000/mm3 and
absence of a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1.5 x upper limit of normal.

- The patient must agree to a biopsy of a sample of tumor for correlative studies.

- The patient is an appropriate candidate for oxaliplatin/capecitabine based

- The patient must have measurable disease.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this study.

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

- Patients may not have received oxaliplatin previously.

- Patients with a prior unanticipated severe reaction to fluoropyrimidine therapy, or
known dihydropyrimidine dehydrogenase (DPD) deficiency, or known hypersensitivity to
platinum compounds or any of the components of the study medications.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen

Outcome Time Frame:

The cycle length is 3 weeks, consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment.

Safety Issue:


Principal Investigator

Ian Rabinowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:




Start Date:

April 2004

Completion Date:

March 2006

Related Keywords:

  • Colonic Diseases
  • Cancer
  • Colorectal Cancer
  • Pilot Study
  • Oxaliplatin
  • Colonic Diseases
  • Colorectal Neoplasms



University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Hematology Oncology Associates Albuquerque, New Mexico  87106
Lovelace Sandia Health Systems Dept of Hematology Albuquerque, New Mexico  87108
New Mexico Veterans Administration Health Care System Albuquerque, New Mexico