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

Primary Purpose

Colonic Diseases, Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Diseases focused on measuring Colorectal Cancer, Pilot Study, Oxaliplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hematology Oncology Associates
  • Lovelace Sandia Health Systems Dept of Hematology
  • University of New Mexico Cancer Center
  • New Mexico Veterans Administration Health Care System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 3, 2005
Last Updated
September 23, 2011
Sponsor
New Mexico Cancer Care Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT00250029
Brief Title
Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy Regimen
Official Title
Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases, Cancer
Keywords
Colorectal Cancer, Pilot Study, Oxaliplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
XELOX (oxaplatin+capecitabine)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Rabinowitz, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology Oncology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-3661
Country
United States
Facility Name
Lovelace Sandia Health Systems Dept of Hematology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
New Mexico Veterans Administration Health Care System
City
Albuquerque
State/Province
New Mexico
Country
United States

12. IPD Sharing Statement

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

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