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Trial record 1 of 1 for:    ECOG E3508
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Paclitaxel, Carboplatin, and Bevacizumab With or Without Cixutumumab in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

This study has been terminated.
(The study was closed to accrual due to the end of the clinical development program with cixutumumab.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00955305
First received: August 7, 2009
Last updated: September 12, 2016
Last verified: September 2016
Results First Received: July 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Large Cell Lung Carcinoma
Lung Adenocarcinoma
Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Bronchioloalveolar Lung Carcinoma
Interventions: Biological: Bevacizumab
Drug: Carboplatin
Biological: Cixutumumab
Drug: Paclitaxel

  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
This study opened to accrual on March 9, 2010 and was suspended on February 24, 2011 for safety evaluation. As the safety criterion was met, this study reopened on May 16, 2011 and closed to accrual on June 28, 2013 due to the end of the clinical development program with cixutumumab (IMC-A12) with final accrual of 175 patients.

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
Arm A (CPB) Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
Arm B (CPB+Cixutumumab) Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Arm A (CPB)   Arm B (CPB+Cixutumumab)
STARTED   88   87 
Treated   83   82 
Eligible and Treated   78   75 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   88   87 
Disease progression                39                41 
Adverse Event                22                22 
Death                2                1 
Withdrawal by Subject                5                4 
Alternative therapy                4                0 
Other complicating disease                2                4 
Physician Decision                1                0 
Continued presence of residual disease                0                1 
Functional decline                2                0 
Maximum response achieved                0                1 
Lost to Follow-up                0                1 
No off-treatment reason submitted                1                0 
Never started protocol treatment                5                5 
Ineligible                5                7 
[1] Treatment continued until disease progression or unacceptable toxicities.



  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.
Eligible and treated patients

Reporting Groups
  Description
Arm A (CPB) Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
Arm B (CPB+Cixutumumab) Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Arm A (CPB)   Arm B (CPB+Cixutumumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 78   75   153 
Age 
[Units: Years]
Median (Full Range)
 64 
 (38 to 82) 
 61 
 (28 to 82) 
 63 
 (28 to 82) 
Gender 
[Units: Participants]
     
Female   40   40   80 
Male   38   35   73 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years ]

3.  Secondary:   Proportion of Patients With Objective Response   [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry; up to 5 years ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012


Publications of Results:
Argiris, A., Lee, J., Leach, J.W., Schiller, J.H.: Safety analysis of a phase II randomized trial of carboplatin (C), Paclitaxel (P), bevacizumab (B) with or without cixutumumab (CX) in patients (pts) with advanced non-squamous, non-small cell lung cancer (NSCLC). J Clin Oncol 2014;31(15s). Abstract e19018.


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00955305     History of Changes
Other Study ID Numbers: NCI-2011-01960
NCI-2011-01960 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E3508 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA180820 ( US NIH Grant/Contract Award Number )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: August 7, 2009
Results First Received: July 26, 2016
Last Updated: September 12, 2016
Health Authority: United States: Food and Drug Administration