Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy Regimen
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy|
- 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 [ Time Frame: The cycle length is 3 weeks, consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment. ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2004|
|Study Completion Date:||March 2006|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2 hour intravenous infusion on day 1 of a three week cycle, prior to the 1st dose of capecitabine. 5-HT3 antagonists with or without dexamethasone premedication are strongly recommended. Oxaliplatin may be infused either through a peripheral vein or a central venous line. The infusion lines must be adequately flushed with 5% dextrose solution (D5W) between oxaliplatin infusion & the administration of any other drug.
Capecitabine is to be administered orally within 30 mins. after the end of a meal. Tablets should be swallowed with approximately 200 mL water (not fruit juices). The first dose of each cycle will be administered as the evening dose on day 1 & the last dose of each cycle is scheduled the morning of day 15, followed by a 7 day rest period. This provides for a total of 28 single doses per cycle over 15 calendar days.
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 followed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250029
|United States, New Mexico|
|Hematology Oncology Associates|
|Albuquerque, New Mexico, United States, 87102-3661|
|Lovelace Sandia Health Systems Dept of Hematology|
|Albuquerque, New Mexico, United States, 87108|
|New Mexico Veterans Administration Health Care System|
|Albuquerque, New Mexico, United States|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Ian Rabinowitz, MD||University of New Mexico|