Trial Information
Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MTD and DLT for the combination therapy of gemcitabine and capecitabine
Outcome Time Frame:
January 2010
Safety Issue:
Yes
Principal Investigator
Philip Gold, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Swedish Medical Center Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
TI027 PG/HK
NCT ID:
NCT00316420
Start Date:
December 2003
Completion Date:
August 2009
Related Keywords:
- Pancreatic Cancer
- Pancreatic Neoplasms
Name | Location |
Swedish Medical Center Cancer Institute |
Seattle, Washington 98104 |