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Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00287989
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Carboplatin
Drug: erlotinib hydrochloride
Drug: Paclitaxel
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 150 PRE 1,500 PRE 1,500 POST
Hide Arm/Group Description Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2 Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2 Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
Period Title: Overall Study
Started 28 29 29
Completed 28 29 29
Not Completed 0 0 0
Arm/Group Title 150 PRE 1,500 PRE 1,500 POST Total
Hide Arm/Group Description Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2 Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2 Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3. Total of all reporting groups
Overall Number of Baseline Participants 28 29 29 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 29 participants 86 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  50.0%
14
  48.3%
14
  48.3%
42
  48.8%
>=65 years
14
  50.0%
15
  51.7%
15
  51.7%
44
  51.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 29 participants 86 participants
68
(51 to 81)
62
(42 to 78)
62
(43 to 81)
64
(42 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 29 participants 86 participants
Female
15
  53.6%
13
  44.8%
15
  51.7%
43
  50.0%
Male
13
  46.4%
16
  55.2%
14
  48.3%
43
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 28 participants 29 participants 29 participants 86 participants
28
 100.0%
29
 100.0%
29
 100.0%
86
 100.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description Percentage of patients who experienced complete or partial response as defined by RECIST
Time Frame after 6 cycles of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 PRE 1,500 PRE 1,500 POST
Hide Arm/Group Description:
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
Overall Number of Participants Analyzed 26 29 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18
(6 to 37)
34
(18 to 54)
28
(13 to 47)
2.Secondary Outcome
Title Time to Progression
Hide Description Median number of months until disease progression
Time Frame after cycle 6 of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 PRE 1,500 PRE 1,500 POST
Hide Arm/Group Description:
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
Overall Number of Participants Analyzed 28 29 29
Median (95% Confidence Interval)
Unit of Measure: months
4
(3 to 5)
4
(3 to 6)
5
(3 to 8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 150 PRE 1,500 PRE 1,500 POST
Hide Arm/Group Description Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2 Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2 Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
All-Cause Mortality
150 PRE 1,500 PRE 1,500 POST
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
150 PRE 1,500 PRE 1,500 POST
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/28 (17.86%)      9/29 (31.03%)      8/29 (27.59%)    
Blood and lymphatic system disorders       
Neutropenia †  5/28 (17.86%)  5 9/29 (31.03%)  9 8/29 (27.59%)  8
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
150 PRE 1,500 PRE 1,500 POST
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/28 (7.14%)      2/29 (6.90%)      2/29 (6.90%)    
Respiratory, thoracic and mediastinal disorders       
Dyspnea †  2/28 (7.14%)  2 2/29 (6.90%)  2 2/29 (6.90%)  2
†
Indicates events were collected by systematic assessment
The design of the study was change during the course of this research.
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
Layout table for Results Point of Contact information
Name/Title: Charles M. Rudin, MD, PhD.
Organization: MSKCC
Phone: 646-888-4527
EMail: rudinc@mskcc.org
Publications of Results:
Riely GJ, Rizvi NA, Kris MG, Milton DT, Solit DB, Rosen N, Senturk E, Azzoli CG, Brahmer JR, Sirotnak FM, Seshan VE, Fogle M, Ginsberg M, Miller VA, Rudin CM. Randomized phase II study of pulse erlotinib before or after carboplatin and paclitaxel in current or former smokers with advanced non-small-cell lung cancer. J Clin Oncol. 2009 Jan 10;27(2):264-70. doi: 10.1200/JCO.2008.17.4656. Epub 2008 Dec 1.
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00287989    
Other Study ID Numbers: J0432
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0432
JHOC-WIRB-20041142
CDR0000455116 ( Other Identifier: other )
20-04-11-42 ( Other Identifier: JHM IRB )
First Submitted: February 6, 2006
First Posted: February 7, 2006
Results First Submitted: March 20, 2017
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018