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Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00338988
First received: June 16, 2006
Last updated: July 27, 2012
Last verified: July 2012
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) ]
  Show Outcome Measure 1


  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
No text entered.  


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: 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 27, 2012
Health Authority: United States: Institutional Review Board