A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Capecitabine; Drug: Gemcitabine

• Registration Number: NCT02565641
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Adult participants 18 to 75 years of age
• Locally advanced or metastatic pancreatic cancer

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Exclusion Criteria

• Prior chemotherapy for pancreatic cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine + Gemcitabine	Capecitabine	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 + Gemcitabine	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).

Primary Outcome Measures

Name	Time	Method
Overall objective response rate	At the end of 6 cycles (24 weeks)

Secondary Outcome Measures

Name	Time	Method
Time to disease progression	Up to approximately 3.5 years
Duration of response	Up to approximately 3.5 years
Overall survival	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
Incidence of adverse events	Up to approximately 3.5 years