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

Pancreatic Cancer Clinical Trial

Official title:

An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565641
• Other study ID #: ML16832
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2015
• Last updated: November 1, 2016
• Start date: March 2003
• Est. completion date: September 2006

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea, republic of: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult participants 18 to 75 years of age

• Locally advanced or metastatic pancreatic cancer

Exclusion Criteria:

• Prior chemotherapy for pancreatic cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall objective response rate		At the end of 6 cycles (24 weeks)	No
Secondary	Duration of response		Up to approximately 3.5 years	No
Secondary	Time to disease progression		Up to approximately 3.5 years	No
Secondary	Time to response		Up to approximately 3.5 years	No
Secondary	Time to treatment failure		Up to approximately 3.5 years	No
Secondary	Overall survival		Up to approximately 3.5 years	No
Secondary	Incidence of adverse events		Up to approximately 3.5 years	No