Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

March 4, 2010 updated by: Swedish Medical Center

Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma

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.

Study Overview

Status

Completed

Conditions

Pancreatic Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

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

Study Locations

United States
- Washington
  - Seattle, Washington, United States, 98104
    - Swedish Medical Center Cancer Institute

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MTD and DLT for the combination therapy of gemcitabine and capecitabine Time Frame: January 2010	January 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor Response Time Frame: January 2010	January 2010

Collaborators and Investigators

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

Sponsor

Swedish Medical Center

Collaborators

Roche Pharma AG

Investigators

Principal Investigator: Philip Gold, MD, Swedish Medical Center Cancer Institute
Principal Investigator: Henry Kaplan, MD, Swedish Medical Center Cancer Institute

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 Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria