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

Completed · Not applicable

Conditions studied: Colonic Diseases, Cancer

In brief

1.1 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. 1.2 To determine a gene expression profile that predicts response to an oxaliplatin based chemotherapy regimen in this cohort of patients.

Key facts

Study ID

NCT00250029

Run by

New Mexico Cancer Research Alliance

People needed

30

Starts

2004-04-01

Expected to finish

2006-03-01

Last updated by the study team

2011-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients, >18 years of age, with metastatic/recurrent colorectal cancer are eligible.
• 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 chemotherapy.
• The patient must have measurable disease.

You may not qualify if…

• 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.

Where it is running

• Hematology Oncology Associates — Albuquerque, New Mexico, United States
• Lovelace Sandia Health Systems Dept of Hematology — Albuquerque, New Mexico, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• New Mexico Veterans Administration Health Care System — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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