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Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00316420
First received: April 18, 2006
Last updated: March 4, 2010
Last verified: March 2010

April 18, 2006
March 4, 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 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00316420 on ClinicalTrials.gov Archive Site
Tumor Response [ Time Frame: January 2010 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316420
TI027 PG/HK
No
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