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

Inclusion Criteria:

- 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.

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.