Back to resultsGemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capecitabine (Xeloda)
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
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
Sites / Locations
- Swedish Medical Center Cancer Institute
Outcomes
Primary Outcome Measures
MTD and DLT for the combination therapy of gemcitabine and capecitabine
Secondary Outcome Measures
Tumor Response
Full Information
NCT ID
NCT00316420
First Posted
April 18, 2006
Last Updated
March 4, 2010
Sponsor
Swedish Medical Center
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT00316420
Brief Title
Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer
Official Title
Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Swedish Medical Center
Collaborators
Roche Pharma AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Capecitabine (Xeloda)
Other Intervention Name(s)
Xeloda
Intervention Description
650 mg/m2 po bid Days 1-14 750 mg/m2 po bid Days 1-14 850 mg/m2 po bid Days 1-14 950 mg/m2 po bid Days 1-14
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
750 mg/m2 IV Days 1 & 8 q 21 days
Primary Outcome Measure Information:
Title
MTD and DLT for the combination therapy of gemcitabine and capecitabine
Time Frame
January 2010
Secondary Outcome Measure Information:
Title
Tumor Response
Time Frame
January 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gold, MD
Organizational Affiliation
Swedish Medical Center Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry Kaplan, MD
Organizational Affiliation
Swedish Medical Center Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Medical Center Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer
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