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 measurement (RECIST criteria)
Secondary Outcome Measures
Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00048139
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 Intermittent Xeloda 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
October 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 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 intermittent oral Xeloda administration in combination with 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
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
250mg/m2 iv on day 1 of each 3 week cycle
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
1000mg/m2 po bid on days 1-15 of each 3 week cycle
Primary Outcome Measure Information:
Title
Tumor measurement (RECIST criteria)
Time Frame
Event driven
Secondary Outcome Measure Information:
Title
Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-1030
Country
United States
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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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