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Trial record 1 of 3 for:    S0709
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S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00661193
First received: April 17, 2008
Last updated: January 10, 2017
Last verified: January 2017
Results First Received: November 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: carboplatin
Drug: erlotinib hydrochloride
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
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
Erlotinib Hydrochloride Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride, Paclitaxel, Carboplatin Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Erlotinib Hydrochloride   Erlotinib Hydrochloride, Paclitaxel, Carboplatin
STARTED   33   26 
COMPLETED   0   0 
NOT COMPLETED   33   26 
Adverse Event                2                1 
Withdrawal by Subject                3                1 
Progression                27                24 
Not protocol specified                1                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
Erlotinib Hydrochloride Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Erlotinib Hydrochloride, Paclitaxel, Carboplatin Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Erlotinib Hydrochloride   Erlotinib Hydrochloride, Paclitaxel, Carboplatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   26   59 
Age 
[Units: Years]
Median (Full Range)
 74.9 
 (45.2 to 84.9) 
 70.8 
 (40.9 to 85.9) 
 72.4 
 (40.9 to 85.9) 
Gender 
[Units: Participants]
Count of Participants
     
Female      19  57.6%      16  61.5%      35  59.3% 
Male      14  42.4%      10  38.5%      24  40.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   3.0%      1   3.8%      2   3.4% 
Not Hispanic or Latino      29  87.9%      22  84.6%      51  86.4% 
Unknown or Not Reported      3   9.1%      3  11.5%      6  10.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2   6.1%      2   7.7%      4   6.8% 
Native Hawaiian or Other Pacific Islander      1   3.0%      0   0.0%      1   1.7% 
Black or African American      1   3.0%      3  11.5%      4   6.8% 
White      29  87.9%      19  73.1%      48  81.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      2   7.7%      2   3.4% 
Histology 
[Units: Participants]
Count of Participants
     
Adenocarcinoma      27  81.8%      23  88.5%      50  84.7% 
Squamous      5  15.2%      2   7.7%      7  11.9% 
Large Cell      0   0.0%      1   3.8%      1   1.7% 
Other      1   3.0%      0   0.0%      1   1.7% 
Smoking History 
[Units: Participants]
Count of Participants
     
Current      10  30.3%      9  34.6%      19  32.2% 
Former      17  51.5%      11  42.3%      28  47.5% 
Never      6  18.2%      6  23.1%      12  20.3% 
Stage 
[Units: Participants]
Count of Participants
     
IIIB      1   3.0%      1   3.8%      2   3.4% 
IV      32  97.0%      25  96.2%      57  96.6% 
Weight Loss Past 6 Months 
[Units: Participants]
Count of Participants
     
<5%      14  42.4%      16  61.5%      30  50.8% 
5-<10%      14  42.4%      7  26.9%      21  35.6% 
10-20%      3   9.1%      1   3.8%      4   6.8% 
>20%      1   3.0%      1   3.8%      2   3.4% 
Unknown      1   3.0%      1   3.8%      2   3.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months   [ Time Frame: From date of registration to 3 years or death, whichever comes first ]

2.  Secondary:   Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease   [ Time Frame: From date of registration to 3 years or death, whichever comes first ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Lung Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-6197
e-mail: jmoon@fredhutch.org



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00661193     History of Changes
Other Study ID Numbers: CDR0000593575
S0709 ( Other Identifier: SWOG )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: April 17, 2008
Results First Received: November 4, 2016
Last Updated: January 10, 2017