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Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00361231
First Posted: August 8, 2006
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Genentech, Inc.
Sanofi
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital
Results First Submitted: December 3, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Biliary Tract Cancer
Gallbladder Adenocarcinoma
Interventions: Drug: Bevacizumab
Drug: Gemcitabine
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bevacizumab, Gemcitabine, Oxaliplatin
  • The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
  • Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
  • Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.

Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.

Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.


Participant Flow:   Overall Study
    Bevacizumab, Gemcitabine, Oxaliplatin
STARTED   35 
COMPLETED   1 
NOT COMPLETED   34 
Physician Decision                3 
Symptomatic deterioration                5 
Radiographic disease progression                16 
Withdrawal by Subject                4 
Adverse Event                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bevacizumab, Gemcitabine, Oxaliplatin
  • The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
  • Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
  • Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.

Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.

Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.


Baseline Measures
   Bevacizumab, Gemcitabine, Oxaliplatin 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      23  65.7% 
>=65 years      12  34.3% 
Age 
[Units: Years]
Median (Full Range)
 60 
 (25 to 82) 
Gender 
[Units: Participants]
Count of Participants
 
Female      14  40.0% 
Male      21  60.0% 
Region of Enrollment 
[Units: Participants]
 
United States   35 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Progression Free Survival   [ Time Frame: 2 years ]

2.  Secondary:   Overall Response Rate   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Andrew X. Zhu
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: azhu@mgh.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andrew X. Zhu, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361231     History of Changes
Other Study ID Numbers: 05-349
First Submitted: August 4, 2006
First Posted: August 8, 2006
Results First Submitted: December 3, 2014
Results First Posted: February 7, 2017
Last Update Posted: February 7, 2017