Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00316420

Enrollment

Registered

2006-04-20

Start date

2003-12-31

Completion date

2009-08-31

Last updated

2010-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Brief summary

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.

Interventions

DRUGCapecitabine (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

DRUGGemcitabine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
MTD and DLT for the combination therapy of gemcitabine and capecitabine	January 2010

Secondary

Measure	Time frame
Tumor Response	January 2010

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026