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Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

NCT00338988 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-08-01

Study results available
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Summary

This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either previously untreated or treated with chemotherapy. Participants will accrue to two strata based on pre-treatment status; separate response rates and statistical operating characteristics will be applied to each stratum.

The primary objective is to determine the objective response rate (complete plus partial) of XELOX in this population.

Secondary objectives include determining toxicity, stable disease rates, and median and overall survival of participants treated with this combination.

Conditions

  • Cancer of the Gallbladder
  • Cancer of the Biliary Tract

Interventions

DRUG

Capecitabine

1500 mg/m\^2 PO twice daily x 14 days.

DRUG

Oxaliplatin

130 mg/m\^2 IV over 2 hours on day 1 of cycle.

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Melanie Thomas, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00338988 on ClinicalTrials.gov