A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer
An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer
1 other identifier
interventional
63
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pancreatic-cancer
Started Mar 2003
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedNovember 2, 2016
November 1, 2016
3.5 years
September 30, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall objective response rate
At the end of 6 cycles (24 weeks)
Secondary Outcomes (6)
Duration of response
Up to approximately 3.5 years
Time to disease progression
Up to approximately 3.5 years
Time to response
Up to approximately 3.5 years
Time to treatment failure
Up to approximately 3.5 years
Overall survival
Up to approximately 3.5 years
- +1 more secondary outcomes
Study Arms (1)
Capecitabine + Gemcitabine
EXPERIMENTALParticipants 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).
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Adult participants 18 to 75 years of age
- Locally advanced or metastatic pancreatic cancer
You may not qualify if:
- \- Prior chemotherapy for pancreatic cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Buchun, 420-021, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Seoul, 135-720, South Korea
Unknown Facility
Seoul, 137-702, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Unknown Facility
Seoul, 158-710, South Korea
Unknown Facility
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 1, 2015
Study Start
March 1, 2003
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
November 2, 2016
Record last verified: 2016-11