Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type NSCLC

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01042288
First received: December 31, 2009
Last updated: March 16, 2016
Last verified: March 2016
Results First Received: March 16, 2016  
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: Pemetrexed
Drug: Panitumumab

  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/Pemetrexed/Panitumumab

Systemic Therapy

Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)

Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)

Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)


Participant Flow:   Overall Study
    Carboplatin/Pemetrexed/Panitumumab  
STARTED     69  
Maintenance     27  
COMPLETED     0 [1]
NOT COMPLETED     69  
[1] Patients remained on maintenance until disease progression, toxicity or other reason to come off



  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/Pemetrexed/Panitumumab

Systemic Therapy

Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)

Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)

Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)


Baseline Measures
    Carboplatin/Pemetrexed/Panitumumab  
Number of Participants  
[units: participants]
  69  
Age  
[units: years]
Median (Full Range)
  65   (50 to 83)  
Gender  
[units: participants]
 
Female     40  
Male     29  
Region of Enrollment  
[units: participants]
 
United States     69  



  Outcome Measures
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1.  Primary:   Median Time to Progression (TTP)   [ Time Frame: 18 months ]

2.  Secondary:   Median Progression-free Survival (PFS)   [ Time Frame: Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months ]

3.  Secondary:   Median Overall Survival (OS)   [ Time Frame: 18 months ]

4.  Secondary:   Objective Response Rate   [ Time Frame: Projected 18 months ]

5.  Secondary:   Frequency of Adverse Events and Severity as a Measure of Toxicity   [ Time Frame: Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter ]


  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: 1-877-691-7274
e-mail: asksarah@scresearch.net



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01042288     History of Changes
Other Study ID Numbers: SCRI LUN 183
Study First Received: December 31, 2009
Results First Received: March 16, 2016
Last Updated: March 16, 2016
Health Authority: United States: Food and Drug Administration