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Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer


2003-12


2009-02


2009-08


20

Study Overview

Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

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.

N/A

  • Pancreatic Cancer
  • DRUG: Capecitabine (Xeloda)
  • DRUG: Gemcitabine
  • TI027 PG/HK

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2006-04-18  

N/A  

2010-03-04  

2006-04-18  

N/A  

2010-03-08  

2006-04-20  

N/A  

2010-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Non Randomized


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
MTD and DLT for the combination therapy of gemcitabine and capecitabineJanuary 2010
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Tumor ResponseJanuary 2010

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Roche Pharma AG

  • PRINCIPAL_INVESTIGATOR: Philip Gold, MD, Swedish Medical Center Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available