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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pamela L. Kunz, Stanford University
ClinicalTrials.gov Identifier:
NCT00398320
First received: October 31, 2006
Last updated: October 15, 2013
Last verified: October 2013
Results First Received: October 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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 1-14 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 verion 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 1-14 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 verion 3.


Baseline Measures
    Capecitabine / Oxaliplatin / Bevacizumab  
Number of Participants  
[units: participants]
  40  
Age  
[units: years]
Median ( Full Range )
  55  
  ( 32 to 76 )  
Gender  
[units: participants]
 
Female     18  
Male     22  
Region of Enrollment  
[units: participants]
 
United States     40  



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

2.  Primary:   Toxicity by CTCAE Version 3.0   [ Time Frame: Assessed at every visit (approx every 3 wks) ]

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

4.  Secondary:   Overall Survival   [ 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
No text entered.


  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
Organization: Stanford University School of Medicine
phone: 650-725-8738
e-mail: pkunz@stanford.edu


No publications provided


Responsible Party: Pamela L. Kunz, Stanford University
ClinicalTrials.gov Identifier: NCT00398320     History of Changes
Other Study ID Numbers: END0002, 97273, END0002
Study First Received: October 31, 2006
Results First Received: October 15, 2013
Last Updated: October 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board