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Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00550537
First received: October 26, 2007
Last updated: May 12, 2017
Last verified: May 2017
Results First Received: March 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: bevacizumab
Drug: carboplatin
Drug: erlotinib hydrochloride
Drug: paclitaxel
Genetic: gene expression analysis
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis

  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
The recruitment period for this trial was October 2007 to July 2011. Participants were recruited at Vanderbilt Medical Center, Emory University, M.D. Anderson Cancer Center, University of Florida - Gainesville.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
10 participants were consented to participate in this trial, but were determined to be ineligible; 3 participants withdrew from the study prior to beginning treatment; 1 participant progressed before beginning treatment.

Reporting Groups
  Description
Treatment

Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.

bevacizumab: 15 mg/m2 given through a vein for every 3 weeks

carboplatin: AUC = 6 given through a vein on day 1 of each cycle.

erlotinib hydrochloride: 150 mg taken by mouth daily

paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.

gene expression analysis: Blood and tissue collection.

protein expression analysis: Blood and tissue collection.

proteomic profiling: Blood and tissue collection.

laboratory biomarker analysis: Blood and tissue collection.


Participant Flow:   Overall Study
    Treatment
STARTED   116 
COMPLETED   12 
NOT COMPLETED   104 
Death                18 
Adverse Event                20 
Disease progression before                46 
Withdrawal by Subject                7 
Change in treatment plan                4 
Other complicating ilness                3 
Declining performance status                2 
Treated closer to home                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
Treatment

Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.

bevacizumab: 15 mg/m2 given through a vein for every 3 weeks

carboplatin: AUC = 6 given through a vein on day 1 of each cycle.

erlotinib hydrochloride: 150 mg taken by mouth daily

paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.

gene expression analysis: Blood and tissue collection.

protein expression analysis: Blood and tissue collection.

proteomic profiling: Blood and tissue collection.

laboratory biomarker analysis: Blood and tissue collection.


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 116 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 116 
   70.9  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 116 
Female      69  59.5% 
Male      47  40.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 116 
Hispanic or Latino      1   0.9% 
Not Hispanic or Latino      112  96.6% 
Unknown or Not Reported      3   2.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 116 
American Indian or Alaska Native      0   0.0% 
Asian      4   3.4% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7   6.0% 
White      102  87.9% 
More than one race      1   0.9% 
Unknown or Not Reported      2   1.7% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed 
[Units: Participants]
 116 
United States   116 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease   [ Time Frame: End of treatment date ]

2.  Secondary:   Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride   [ Time Frame: End of treatment date ]

3.  Secondary:   Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride   [ Time Frame: End of treatment date ]

4.  Secondary:   Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment   [ Time Frame: End of treatment date ]

5.  Secondary:   Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers   [ Time Frame: End of treatment date ]

6.  Secondary:   Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy   [ Time Frame: End of treatment date ]

7.  Secondary:   Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC   [ Time Frame: Through study completion, an average of 1 year ]

8.  Secondary:   Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC   [ Time Frame: Through study completion, an average of 1 year ]

9.  Secondary:   Number of Patients With Worst-grade Toxicities Per Grade   [ Time Frame: Through study completion, an average of 1 year ]

10.  Secondary:   Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC   [ Time Frame: Through study completion, an average of 1 year ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Leora Horn, Principal Investigator
Organization: Vanderbilt-Ingram Cancer Center
e-mail: leora.horn@vanderbilt.edu



Responsible Party: Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00550537     History of Changes
Other Study ID Numbers: VICC-THO-0640
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-THO-0640
VU-VICC-070494
Study First Received: October 26, 2007
Results First Received: March 14, 2017
Last Updated: May 12, 2017