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Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398320
First Posted: November 10, 2006
Last Update Posted: March 1, 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.
Information provided by (Responsible Party):
Pamela L. Kunz, Stanford University
Results First Submitted: October 15, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neuroendocrine Tumors
Interventions: Drug: Capecitabine
Drug: Oxaliplatin
Drug: Bevacizumab

  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
Patients were enrolled at one site in the US over a three-year period.

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
Capecitabine / Oxaliplatin / Bevacizumab

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

Adverse events (AEs) reported are related and grade 3 or higher per CTCAE version 3.


Participant Flow:   Overall Study
    Capecitabine / Oxaliplatin / Bevacizumab
STARTED   40 
COMPLETED   34 
NOT COMPLETED   6 
Death                1 
Adverse Event                4 
Physician Decision                1 



  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
Capecitabine / Oxaliplatin / Bevacizumab

Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle

Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle

Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle

AEs reported are related and grade 3 or higher per CTCAE version 3.


Baseline Measures
   Capecitabine / Oxaliplatin / Bevacizumab 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 55 
 (32 to 76) 
Gender 
[Units: Participants]
Count of Participants
 
Female      18  45.0% 
Male      22  55.0% 
Region of Enrollment 
[Units: Participants]
 
United States   40 


  Outcome Measures
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1.  Primary:   12-month Progression Free Survival (PFS)   [ Time Frame: PFS assessed every 3 months through 12 months ]

2.  Primary:   Number of Patients Who Experienced Treatment-related Grade 3 or Higher Adverse Events by CTCAE Version 3.0   [ Time Frame: 30 days after last treatment ]

3.  Secondary:   Response Rates   [ Time Frame: Response rates by RECIST criteria assessed every 3 months while on treatment ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Continuous ]

5.  Secondary:   Biochemical Markers   [ Time Frame: Assessed every 3 weeks while on treatment ]


  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: Pamela L Kunz, MD
Organization: Stanford University School of Medicine
phone: 650-725-8738
e-mail: pkunz@stanford.edu



Responsible Party: Pamela L. Kunz, Stanford University
ClinicalTrials.gov Identifier: NCT00398320     History of Changes
Other Study ID Numbers: IRB-06233
97273
NET0002 ( Other Identifier: OnCore )
END0002 (formerly) ( Other Identifier: OnCore )
First Submitted: October 31, 2006
First Posted: November 10, 2006
Results First Submitted: October 15, 2013
Results First Posted: December 10, 2013
Last Update Posted: March 1, 2017