Status:
COMPLETED
Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy Regimen
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Colonic Diseases
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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....
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00250029
Start Date
April 1 2004
End Date
March 1 2006
Last Update
September 27 2011
Active Locations (4)
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1
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87102-3661
2
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, United States, 87108
3
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
4
New Mexico Veterans Administration Health Care System
Albuquerque, New Mexico, United States