Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126581
First received: August 2, 2005
Last updated: June 18, 2014
Last verified: June 2014
Results First Received: October 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Lung
Adenosquamous Cell Lung Cancer
Bronchoalveolar Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions: Drug: erlotinib hydrochloride
Drug: paclitaxel
Drug: carboplatin

  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
Between August 2005 and April 2009, 188 participants were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven participants withdrew consent before initiating study therapy, therefore, 181 participants were randomized to either arm.

Reporting Groups
  Description
Arm A: Erlotinib Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm B: Erlotinib/Carboplatin/Paclitaxel Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.

Participant Flow:   Overall Study
    Arm A: Erlotinib     Arm B: Erlotinib/Carboplatin/Paclitaxel  
STARTED     81     100  
COMPLETED     68     80  
NOT COMPLETED     13     20  
Adverse Event                 3                 7  
Death                 3                 2  
Withdrawal by Subject                 1                 4  
Alternative therapy                 3                 3  
Other illness/MD discretion                 3                 4  



  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
Arm A: Erlotinib Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm B: Erlotinib/Carboplatin/Paclitaxel Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
Total Total of all reporting groups

Baseline Measures
    Arm A: Erlotinib     Arm B: Erlotinib/Carboplatin/Paclitaxel     Total  
Number of Participants  
[units: participants]
  81     100     181  
Age  
[units: years]
Median ( Full Range )
  58  
  ( 32 to 78 )  
  60  
  ( 34 to 81 )  
  59  
  ( 32 to 81 )  
Gender  
[units: participants]
     
Female     49     58     107  
Male     32     42     74  
Region of Enrollment  
[units: participants]
     
United States     81     100     181  
ECOG Performance Status [1]
[units: participants]
     
0 - fully active     50     48     98  
1 - minimal symptoms     31     52     83  
Smoking history  
[units: participants]
     
Never smoker     64     79     143  
Light former smoker     17     21     38  
Histology  
[units: participants]
     
Adenocarcinoma     71     84     155  
Bronhioloalveolar cancer     2     2     4  
Adenocarcinoma with bronchioloalveolar features     8     14     22  
[1] Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).



  Outcome Measures
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1.  Primary:   18 Weeks Progression Free Survival (PFS) Rate   [ Time Frame: At 18 weeks ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Duration of Study (up to 3 years) ]

3.  Secondary:   Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.   [ Time Frame: Duration of study (up to 3 years) ]

4.  Other Pre-specified:   Overall Survival   [ Time Frame: Time from randomization to death (up to 3 years) ]

5.  Other Pre-specified:   Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status   [ Time Frame: Duration of treatment (up to 3 years) ]

6.  Other Pre-specified:   Overall Response Rate by EGFR Mutation Status   [ Time Frame: Duration of study (up to 3 years) ]

7.  Other Pre-specified:   Progression Free Survival With KRAS Mutation Status   [ Time Frame: Duration of study (up to 3 years) ]

8.  Other Pre-specified:   Overall Response Rate With KRAS Mutational Status   [ Time Frame: Duration of study (up to 3 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: Pasi Janne, MD, PhD
Organization: Dana-Farber Cancer Institute
e-mail: pjanne@partners.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126581     History of Changes
Other Study ID Numbers: NCI-2009-00464, NCI-2009-00464, CDR0000437097, CALGB 30406, CALGB-30406, U10CA031946, P30CA014236
Study First Received: August 2, 2005
Results First Received: October 7, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration