Back to resultsA Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Irinotecan
capecitabine [Xeloda]
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: adult patients >=18 years of age; locally advanced and/or metastatic colorectal cancer; >=1 target lesion. Exclusion Criteria: previous treatment with Xeloda or irinotecan; previous systemic therapy for metastatic disease; progressive disease during previous adjuvant therapy or within 6 months of completion.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Tumor measurements (RECIST criteria)
Secondary Outcome Measures
Time to progression, time to response, duration of response, time to treatment failure, survival.\n
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00048126
Brief Title
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
Official Title
An Open-label Study of the Effect of Continuous Xeloda Therapy in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
1000mg po bid
Primary Outcome Measure Information:
Title
Tumor measurements (RECIST criteria)
Time Frame
Event driven
Secondary Outcome Measure Information:
Title
Time to progression, time to response, duration of response, time to treatment failure, survival.\n
Time Frame
Event driven
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients >=18 years of age;
locally advanced and/or metastatic colorectal cancer;
>=1 target lesion.
Exclusion Criteria:
previous treatment with Xeloda or irinotecan;
previous systemic therapy for metastatic disease;
progressive disease during previous adjuvant therapy or within 6 months of completion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-1030
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
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