Back to resultsA Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Capecitabine
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult participants 18 to 75 years of age
- Locally advanced or metastatic pancreatic cancer
Exclusion Criteria:
- Prior chemotherapy for pancreatic cancer
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine + Gemcitabine
Arm Description
Participants will receive oral capecitabine (830 milligrams per meter-squared [mg/m^2]) twice daily (BID) as intermittent treatment (Days 1 to 21 every 4 weeks [q4w]) along with IV infusion of gemcitabine (1000 mg/m^2) once weekly as intermittent treatment (4-week cycles of 3-week treatment period and 1-week rest period).
Outcomes
Primary Outcome Measures
Overall objective response rate
Secondary Outcome Measures
Duration of response
Time to disease progression
Time to response
Time to treatment failure
Overall survival
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02565641
Brief Title
A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer
Official Title
An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 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 and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic 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
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine + Gemcitabine
Arm Type
Experimental
Arm Description
Participants will receive oral capecitabine (830 milligrams per meter-squared [mg/m^2]) twice daily (BID) as intermittent treatment (Days 1 to 21 every 4 weeks [q4w]) along with IV infusion of gemcitabine (1000 mg/m^2) once weekly as intermittent treatment (4-week cycles of 3-week treatment period and 1-week rest period).
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine will be administered orally at 830 mg/m^2 BID (equivalent to a total daily dose of 1660 mg/m^2) as intermittent treatment (given days 1 to 21 q4w).
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered at a dose of 1000 mg/m^2 once weekly via IV infusion as intermittent treatment (repeated 4-week cycles of 3 weeks treatment and 1 week rest).
Primary Outcome Measure Information:
Title
Overall objective response rate
Time Frame
At the end of 6 cycles (24 weeks)
Secondary Outcome Measure Information:
Title
Duration of response
Time Frame
Up to approximately 3.5 years
Title
Time to disease progression
Time Frame
Up to approximately 3.5 years
Title
Time to response
Time Frame
Up to approximately 3.5 years
Title
Time to treatment failure
Time Frame
Up to approximately 3.5 years
Title
Overall survival
Time Frame
Up to approximately 3.5 years
Title
Incidence of adverse events
Time Frame
Up to approximately 3.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult participants 18 to 75 years of age
Locally advanced or metastatic pancreatic cancer
Exclusion Criteria:
- Prior chemotherapy for pancreatic cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Facility Information:
City
Buchun
ZIP/Postal Code
420-021
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-702
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer
We'll reach out to this number within 24 hrs