Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00360360
First received: August 2, 2006
Last updated: November 11, 2013
Last verified: November 2013
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasm, Unknown Primary
Interventions: Drug: paclitaxel
Drug: carboplatin
Drug: bevacizumab
Drug: erlotinib

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily

Participant Flow:   Overall Study
    Bevacizumab/Paclitaxel/Carboplatin/Erlotinib  
STARTED     60  
COMPLETED     54  
NOT COMPLETED     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.
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Reporting Groups
  Description
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily

Baseline Measures
    Bevacizumab/Paclitaxel/Carboplatin/Erlotinib  
Number of Participants  
[units: participants]
  60  
Age  
[units: years]
Median ( Full Range )
  50  
  ( 23 to 81 )  
Gender  
[units: participants]
 
Female     31  
Male     29  
Region of Enrollment  
[units: participants]
 
United States     60  



  Outcome Measures
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1.  Primary:   Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death   [ Time Frame: 18 months ]

2.  Secondary:   Progression-free Survival   [ Time Frame: 18 months ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-MY-1-SCRI
e-mail: asksarah@scresearch.net


Publications of Results:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00360360     History of Changes
Other Study ID Numbers: SCRI UNKPRI 19
Study First Received: August 2, 2006
Results First Received: August 15, 2013
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration