A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT02565641
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2003-03-31
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Capecitabine + Gemcitabine
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).
Capecitabine
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
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).
Interventions
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Capecitabine
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
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Locally advanced or metastatic pancreatic cancer
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role:
Hoffmann-La Roche
Locations
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Buchun, , South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Countries
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Other Identifiers
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ML16832
Identifier Type: -
Identifier Source: org_study_id