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Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00741988
First received: August 25, 2008
Last updated: March 29, 2013
Last verified: March 2013
Results First Received: January 23, 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: Non-Small Cell Lung Cancer
Interventions: Drug: Ixabepilone
Drug: Carboplatin
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
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Reporting Groups
  Description
Ixabepilone/Carboplatin ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Ixabepilone/Carboplatin/Bevacizumab ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.

Participant Flow:   Overall Study
    Ixabepilone/Carboplatin     Ixabepilone/Carboplatin/Bevacizumab  
STARTED     42     40  
COMPLETED     38     36  
NOT COMPLETED     4     4  
Adverse Event                 2                 4  
Lack of Efficacy                 2                 0  



  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
Ixabepilone/Carboplatin ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Ixabepilone/Carboplatin/Bevacizumab ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
Total Total of all reporting groups

Baseline Measures
    Ixabepilone/Carboplatin     Ixabepilone/Carboplatin/Bevacizumab     Total  
Number of Participants  
[units: participants]
  42     40     82  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 43 to 85 )  
  63  
  ( 45 to 78 )  
  63  
  ( 43 to 85 )  
Gender  
[units: participants]
     
Female     18     21     39  
Male     24     19     43  
Region of Enrollment  
[units: participants]
     
United States     42     40     82  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment   [ Time Frame: 18 months ]

2.  Secondary:   Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease   [ Time Frame: 18 months ]

3.  Secondary:   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 ]

4.  Secondary:   Characterization of the Toxicity in Patients With Previously Untreated Advanced NSCLC Treated With Ixabepilone and Carboplatin With and Without Bevacizumab.   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


Publications of Results:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00741988     History of Changes
Other Study ID Numbers: SCRI LUN 179
Study First Received: August 25, 2008
Results First Received: January 23, 2013
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board