Back to resultsOxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: no prior treatment for metastatic disease PS 0-2 measurable disease Exclusion Criteria: neuropathy > or equal to grade 2 concomitant radiation therapy or other systemic cancer therapies brain mets
Sites / Locations
- University of Wisconsin
Outcomes
Primary Outcome Measures
Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients
Secondary Outcome Measures
Is the oral drug an advantage in this patient population
Full Information
NCT ID
NCT00205322
First Posted
September 13, 2005
Last Updated
November 15, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00205322
Brief Title
Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer
Official Title
A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both patient convenience and lack of associated catheter-related complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)
Primary Outcome Measure Information:
Title
Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients
Time Frame
Bi-monthly collection of information regarding tumor progression and overall survival.
Secondary Outcome Measure Information:
Title
Is the oral drug an advantage in this patient population
Time Frame
Bi-monthly collection of information regarding tumor progression and overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
no prior treatment for metastatic disease
PS 0-2
measurable disease
Exclusion Criteria:
neuropathy > or equal to grade 2
concomitant radiation therapy or other systemic cancer therapies
brain mets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Mulkerin, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer
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