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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Treatments: Capecitabine; Oxaliplatin

Criteria

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.