Clinical trialNCT00338988CompletedPhase 2Interventional

Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

SponsorM.D. Anderson Cancer CenterEnrollment44Cancer of the Biliary TractCancer of the Gallbladder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Melanie Thomas, MD
M.D. Anderson Cancer Center
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

U.T. M.D. Anderson Cancer Center
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Capecitabine →Oxaliplatin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2003
Primary completion: 31 May 2009
Completion: 31 May 2009
Last update posted: 1 Aug 2012
Registered enrollment: 44
Registry id: NCT00338988

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.