Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

Swedish Medical Center

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: Capecitabine (Xeloda)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00316420

TI027 PG/HK

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)