Back to resultsA Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
Bulgaria
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult patients greater than or equal to (>=) 18 years of age
- Metastatic colorectal cancer
Exclusion Criteria:
- Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease
- Central nervous system and bone metastases
- Moderate or severe renal impairment
- Clinically significant cardiac disease
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
- Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine
Arm Description
Participants will receive oral capecitabine 1250 milligrams per square meter (mg/m^2) twice daily for 14 days followed by 7 day rest period for 6 cycles.
Outcomes
Primary Outcome Measures
Incidence of adverse events
Response rate, ie, percentage of participants with complete, partial, and overall response
Secondary Outcome Measures
Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02567331
Brief Title
A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer
Official Title
An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (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 evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine
Arm Type
Experimental
Arm Description
Participants will receive oral capecitabine 1250 milligrams per square meter (mg/m^2) twice daily for 14 days followed by 7 day rest period for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Participants will receive 1250 mg/m^2 capecitabine administered twice daily as oral tablets for 14 days followed by a 7 day rest period for up to 6 treatment cycles.
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
up to approximately 1.5 years
Title
Response rate, ie, percentage of participants with complete, partial, and overall response
Time Frame
up to approximately 1.5 years
Secondary Outcome Measure Information:
Title
Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n
Time Frame
up to approximately 1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients greater than or equal to (>=) 18 years of age
Metastatic colorectal cancer
Exclusion Criteria:
Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease
Central nervous system and bone metastases
Moderate or severe renal impairment
Clinically significant cardiac disease
Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
8000
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer
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