Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

This study has been completed.

Study NCT00338988 Information provided by M.D. Anderson Cancer Center

First Received on June 16, 2006. Last Updated on July 26, 2011 History of Changes

Results First Received: November 3, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Cancer of the Gallbladder Cancer of the Biliary Tract
Interventions:	Drug: Capecitabine Drug: Oxaliplatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period: August 28, 2003 to July 31, 2006. All participants were recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following enrollment, one of the forty-four participants was found to be ineligible and never assigned to a group.

Reporting Groups

	Description
Capecitabine + Oxaliplatin	Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.

Participant Flow: Overall Study

	Capecitabine + Oxaliplatin
STARTED	44
COMPLETED	43
NOT COMPLETED	1

Baseline Characteristics

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Reporting Groups

	Description
Capecitabine + Oxaliplatin	Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.

Baseline Measures

	Capecitabine + Oxaliplatin
Number of Participants [units: participants]	44
Age [units: years] Median ( Full Range )	68 ( 28 to 77 )
Gender [units: participants]
Female	27
Male	17
Region of Enrollment [units: participants]
United States	44

Outcome Measures

1. Primary:

Number of Participants With Objective Response [ Time Frame: Baseline with restaging every 3 cycles (cycle=21 days) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Melanie Thomas, MD/Assistant Professor
Organization: University Texas MD Anderson Cancer Center
phone: 713-794-4869
e-mail: mjlim@mdanderson.org

No publications provided

Responsible Party:	Melanie Thomas, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00338988 History of Changes
Other Study ID Numbers:	2003-0340
Study First Received:	June 16, 2006
Results First Received:	November 3, 2010
Last Updated:	July 26, 2011
Health Authority:	United States: Institutional Review Board