Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00316420
• Lead Sponsor: Swedish Medical Center

Brief Summary

The purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-20
• Primary Completion: 2009-02
• Study Completion: 2009-08
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-04
• Last Update Posted: 2010-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Metastatic or unresectable pancreatic cancer
• No prior chemotherapy except radiation-sensitizing doses of 5-FU
• No radiotherapy less than 4 weeks prior to the start of the study

Exclusion Criteria

• Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
• Moderate to severe renal impairment
• Uncontrolled diabetes
• Inability to swallow tablets

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MTD and DLT for the combination therapy of gemcitabine and capecitabine	January 2010

Secondary Outcome Measures

Name	Time	Method
Tumor Response	January 2010

Trial Locations

Locations (1)

Swedish Medical Center Cancer Institute; 🇺🇸 Seattle, Washington, United States