We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00316420
First Posted: April 20, 2006
Last Update Posted: March 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Pharma AG
Information provided by:
Swedish Medical Center
April 18, 2006
April 20, 2006
March 8, 2010
December 2003
February 2009   (Final data collection date for primary outcome measure)
MTD and DLT for the combination therapy of gemcitabine and capecitabine [ Time Frame: January 2010 ]
Not Provided
Complete list of historical versions of study NCT00316420 on ClinicalTrials.gov Archive Site
Tumor Response [ Time Frame: January 2010 ]
Not Provided
Not Provided
Not Provided
 
Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: Capecitabine (Xeloda)
    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
    Other Name: Xeloda
  • Drug: Gemcitabine
    750 mg/m2 IV Days 1 & 8 q 21 days
    Other Name: Gemzar
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00316420
TI027 PG/HK
No
Not Provided
Not Provided
Philip Gold, M.D., Swedish Medical Center, Swedish Cancer Insitute
Swedish Medical Center
Roche Pharma AG
Principal Investigator: Philip Gold, MD Swedish Medical Center Cancer Institute
Principal Investigator: Henry Kaplan, MD Swedish Medical Center Cancer Institute
Swedish Medical Center
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP