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Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers

NCT00626158 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-04-04

No results posted yet for this study

Summary

The purpose of this study is to find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These two drugs used together are considered an acceptable standard of care for pancreatic and biliary cancers. However, in this study the dose and dosing schedule will be changed, in the hopes that the drugs will have more effect with fewer side effects than when given in the standard way.

Conditions

Interventions

DRUG

gemcitabine

1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days)

DRUG

capecitabine

starting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days)

Sponsors & Collaborators

Principal Investigators

  • Andrew Ko, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626158 on ClinicalTrials.gov