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Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung

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ClinicalTrials.gov Identifier: NCT00391586
Recruitment Status : Terminated (PI left institution.)
First Posted : October 24, 2006
Results First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: Erlotinib
Drug: Platinum-based chemotherapy
Enrollment 45
Recruitment Details Recruitment began 07/13/2006 and ended 02/09/2009. All patients were recruited through medical clinics in New Mexico, USA.
Pre-assignment Details  
Arm/Group Title Erlotinib Followed by Chemotherapy
Hide Arm/Group Description Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Period Title: Overall Study
Started 45
Received First-line Erlotinib 43 [1]
Received Platinum-based Chemotherapy 10 [2]
Completed 21 [3]
Not Completed 24
Reason Not Completed
Progressive disease             13
Adverse Event             5
Physician Decision             2
Death             4
[1]
These patients received at least one dose of on-study first-line erlotinib
[2]
Total number of patients who received platinum-based chemotherapy after erlotinib treatment
[3]
These patients received at least 2 cycles of erlotinib
Arm/Group Title Erlotinib Followed by Chemotherapy
Hide Arm/Group Description Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
These are patients who received at least one dose of on-study erlotinib
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants
68
(46 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
23
  53.5%
Male
20
  46.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early; no results are available. The number of patients who completed treatment and therefore the number of evaluable patients was too low to accurately calculate endpoints.
Arm/Group Title Erlotinib Followed by Chemotherapy
Hide Arm/Group Description:
Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Toxicity Profile
Hide Description Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.
Time Frame 28 days after last on-study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib Followed by Chemotherapy
Hide Arm/Group Description:
Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
Acne 1
Anorexia 1
Confusion 1
Dehydration 1
Diarrhea 2
Dyspnea 3
Fatigue 8
Nasal hemorrhage 1
Insomnia 1
Kidney pain 1
Lymphocyte count decreased 1
Muscle weakness 1
Neutrophil count decreased 2
Desquamating rash 1
Syncope 1
Thrombosis (clotting) 1
Time Frame Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib Followed by Chemotherapy
Hide Arm/Group Description Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
All-Cause Mortality
Erlotinib Followed by Chemotherapy
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Erlotinib Followed by Chemotherapy
Affected / at Risk (%) # Events
Total   5/43 (11.63%)    
Blood and lymphatic system disorders   
Thrombosis (Clotting) * 1  1/43 (2.33%)  1
Endocrine disorders   
Glucose intolerance * 1  1/43 (2.33%)  1
General disorders   
Ear, nose, and throat examination abnormal * 1 [1]  1/43 (2.33%)  1
Death * 1  1/43 (2.33%)  1
Nervous system disorders   
Seizure * 1  1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis * 1  1/43 (2.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 3.0
[1]
Sore throat, dysphagia (trouble swallowing), and painful lymph node
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib Followed by Chemotherapy
Affected / at Risk (%) # Events
Total   25/43 (58.14%)    
Gastrointestinal disorders   
Anorexia (loss of appetite) * 1  8/43 (18.60%)  13
Constipation * 1  5/43 (11.63%)  5
Diarrhea * 1  9/43 (20.93%)  16
Nausea * 1  9/43 (20.93%)  9
Taste alteration * 1  7/43 (16.28%)  9
Vomiting * 1  4/43 (9.30%)  5
General disorders   
Fatigue * 1  13/43 (30.23%)  25
Fever * 1  3/43 (6.98%)  3
Chest pain * 1  5/43 (11.63%)  5
Nervous system disorders   
Dizziness * 1  3/43 (6.98%)  3
Insomnia * 1  3/43 (6.98%)  6
Peripheral sensory neuropathy * 1  3/43 (6.98%)  4
Respiratory, thoracic and mediastinal disorders   
Cough * 1  4/43 (9.30%)  4
Dyspnea (Shortness of breath) * 1  8/43 (18.60%)  8
Pleural effusion (Fluid collection in lung lining) * 1  3/43 (6.98%)  3
Skin and subcutaneous tissue disorders   
Acne * 1  9/43 (20.93%)  13
Alopecia (Hair loss) * 1  5/43 (11.63%)  5
Rash * 1  7/43 (16.28%)  9
Dry skin * 1  4/43 (9.30%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Dennie Jones, MD
Organization: Dana Farber Cancer Institute
Phone: 617-632-6478
EMail: DennieV_Jones@DFCI.HARVARD.EDU
Layout table for additonal information
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00391586    
Other Study ID Numbers: INST 0601C
NCI-2012-01264 ( Registry Identifier: NCI CTRP )
First Submitted: October 23, 2006
First Posted: October 24, 2006
Results First Submitted: June 15, 2015
Results First Posted: August 17, 2015
Last Update Posted: August 17, 2015