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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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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 InstituteSeattle, Washington  98104