Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

Swedish Medical Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Capecitabine (Xeloda)DRUG

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

GemcitabineDRUG

750 mg/m2 IV Days 1 \& 8 q 21 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Swedish Medical Center Cancer Institute

Seattle, Washington, United States

Outcomes

Primary Outcomes

MTD and DLT for the combination therapy of gemcitabine and capecitabine

Time frame: January 2010

Secondary Outcomes

Tumor Response

Time frame: January 2010

Data from ClinicalTrials.gov

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