Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC

This study has been terminated.
(Study was terminated due to slow accrual)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00960297
First received: August 13, 2009
Last updated: November 8, 2013
Last verified: November 2013
Results First Received: August 27, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: Carboplatin
Drug: Paclitaxel
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
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
Carboplatin/Paclitaxel/Bevacizumab

Preoperative chemotherapy and bevacizumab

Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)

Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64

Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64


Participant Flow:   Overall Study
    Carboplatin/Paclitaxel/Bevacizumab  
STARTED     4  
COMPLETED     1  
NOT COMPLETED     3  
Physician Decision                 1  
Venous port infection                 1  
Disease progression                 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
Carboplatin/Paclitaxel/Bevacizumab

Preoperative chemotherapy and bevacizumab

Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)

Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64

Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64


Baseline Measures
    Carboplatin/Paclitaxel/Bevacizumab  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     2  
Gender  
[units: participants]
 
Female     2  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures

1.  Primary:   To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection.   [ Time Frame: 36 months ]

2.  Secondary:   To Assess Clinical & Pathologic Response Rate, Complete Resection Rate, Toxicity, Progression-free Survival, & Overall Survival.   [ Time Frame: 60 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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.


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: David R. Spigel, M.D.
Organization: Study Chair
phone: 1-877-MY-1-SCRI
e-mail: David.Spigel@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00960297     History of Changes
Other Study ID Numbers: SCRI LUN 144
Study First Received: August 13, 2009
Results First Received: August 27, 2013
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration