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A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00130728
First received: August 12, 2005
Last updated: September 26, 2011
Last verified: September 2011
Results First Received: November 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: bevacizumab
Drug: erlotinib HCl
Drug: placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Participant Flow:   Overall Study
    Erlotinib HCl + Bevacizumab   Erlotinib HCl + Placebo
STARTED   319   317 
Received Study Drug (Safety Population)   313   313 
COMPLETED   108   104 
NOT COMPLETED   211   213 
Death                207                211 
Lost to Follow-up                4                0 
Withdrawal by Subject                0                2 



  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.
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Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
Total Total of all reporting groups

Baseline Measures
   Erlotinib HCl + Bevacizumab   Erlotinib HCl + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 319   317   636 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.8  (10.4)   65.0  (10.3)   64.9  (10.4) 
Age, Customized 
[Units: Participants]
     
Between 18 and 59 years   91   90   181 
Between 60 and 64 years   62   66   128 
Between 65 and 69 years   59   53   112 
>= 70 years   107   108   215 
Gender 
[Units: Participants]
     
Female   148   147   295 
Male   171   170   341 


  Outcome Measures
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1.  Primary:   Overall Survival (OS) Among All Randomized Patients   [ Time Frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years) ]

3.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: The median duration of Objective response was up to 9.7 months ]

4.  Secondary:   Duration of Objective Response   [ Time Frame: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months) ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Up to 3 years
Additional Description Safety Evaluable Population

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Other Adverse Events
    Erlotinib HCl + Bevacizumab   Erlotinib HCl + Placebo
Total, other (not including serious) adverse events     
# participants affected / at risk   310/313 (99.04%)   306/313 (97.76%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   19/313 (6.07%)   29/313 (9.27%) 
Gastrointestinal disorders     
Diarrhoea † 1     
# participants affected / at risk   203/313 (64.86%)   162/313 (51.76%) 
Nausea † 1     
# participants affected / at risk   121/313 (38.66%)   99/313 (31.63%) 
Vomiting † 1     
# participants affected / at risk   57/313 (18.21%)   49/313 (15.65%) 
Constipation † 1     
# participants affected / at risk   49/313 (15.65%)   45/313 (14.38%) 
Stomatitis † 1     
# participants affected / at risk   40/313 (12.78%)   27/313 (8.63%) 
Abdominal Pain † 1     
# participants affected / at risk   29/313 (9.27%)   25/313 (7.99%) 
Dyspepsia † 1     
# participants affected / at risk   21/313 (6.71%)   16/313 (5.11%) 
Dysphagia † 1     
# participants affected / at risk   19/313 (6.07%)   12/313 (3.83%) 
Gastrooesophageal Reflux Disease † 1     
# participants affected / at risk   18/313 (5.75%)   10/313 (3.19%) 
General disorders     
Fatigue † 1     
# participants affected / at risk   146/313 (46.65%)   124/313 (39.62%) 
Pyrexia † 1     
# participants affected / at risk   33/313 (10.54%)   23/313 (7.35%) 
Asthenia † 1     
# participants affected / at risk   34/313 (10.86%)   20/313 (6.39%) 
Chest Pain † 1     
# participants affected / at risk   27/313 (8.63%)   24/313 (7.67%) 
Oedema Peripheral † 1     
# participants affected / at risk   18/313 (5.75%)   32/313 (10.22%) 
Mucosal Inflammation † 1     
# participants affected / at risk   35/313 (11.18%)   16/313 (5.11%) 
Pain † 1     
# participants affected / at risk   15/313 (4.79%)   18/313 (5.75%) 
Chills † 1     
# participants affected / at risk   23/313 (7.35%)   11/313 (3.51%) 
Infections and infestations     
Urinary Tract Infection † 1     
# participants affected / at risk   33/313 (10.54%)   26/313 (8.31%) 
Upper Respiratory Tract Infection † 1     
# participants affected / at risk   30/313 (9.58%)   30/313 (9.58%) 
Pneumonia † 1     
# participants affected / at risk   9/313 (2.88%)   16/313 (5.11%) 
Bronchitis † 1     
# participants affected / at risk   10/313 (3.19%)   18/313 (5.75%) 
Sinusitis † 1     
# participants affected / at risk   16/313 (5.11%)   8/313 (2.56%) 
Investigations     
Weight Decreased † 1     
# participants affected / at risk   65/313 (20.77%)   41/313 (13.10%) 
Metabolism and nutrition disorders     
Anorexia † 1     
# participants affected / at risk   104/313 (33.23%)   75/313 (23.96%) 
Dehydration † 1     
# participants affected / at risk   35/313 (11.18%)   24/313 (7.67%) 
Decreased Appetite † 1     
# participants affected / at risk   36/313 (11.50%)   21/313 (6.71%) 
Hypokalaemia † 1     
# participants affected / at risk   17/313 (5.43%)   21/313 (6.71%) 
Musculoskeletal and connective tissue disorders     
Back Pain † 1     
# participants affected / at risk   46/313 (14.70%)   41/313 (13.10%) 
Arthralgia † 1     
# participants affected / at risk   37/313 (11.82%)   27/313 (8.63%) 
Musculoskeletal Pain † 1     
# participants affected / at risk   34/313 (10.86%)   23/313 (7.35%) 
Pain in Extremity † 1     
# participants affected / at risk   24/313 (7.67%)   20/313 (6.39%) 
Musculoskeletal Chest Pain † 1     
# participants affected / at risk   19/313 (6.07%)   15/313 (4.79%) 
Muscle Spasms † 1     
# participants affected / at risk   16/313 (5.11%)   17/313 (5.43%) 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   53/313 (16.93%)   28/313 (8.95%) 
Dizziness † 1     
# participants affected / at risk   41/313 (13.10%)   31/313 (9.90%) 
Dysgeusia † 1     
# participants affected / at risk   29/313 (9.27%)   19/313 (6.07%) 
Psychiatric disorders     
Insomnia † 1     
# participants affected / at risk   38/313 (12.14%)   25/313 (7.99%) 
Anxiety † 1     
# participants affected / at risk   26/313 (8.31%)   30/313 (9.58%) 
Depression † 1     
# participants affected / at risk   31/313 (9.90%)   19/313 (6.07%) 
Renal and urinary disorders     
Proteinuria † 1     
# participants affected / at risk   18/313 (5.75%)   8/313 (2.56%) 
Dysuria † 1     
# participants affected / at risk   16/313 (5.11%)   6/313 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   73/313 (23.32%)   76/313 (24.28%) 
Dyspnoea † 1     
# participants affected / at risk   61/313 (19.49%)   64/313 (20.45%) 
Epistaxis † 1     
# participants affected / at risk   63/313 (20.13%)   30/313 (9.58%) 
Pharyngolaryngeal Pain † 1     
# participants affected / at risk   27/313 (8.63%)   14/313 (4.47%) 
Dysphonia † 1     
# participants affected / at risk   33/313 (10.54%)   6/313 (1.92%) 
Haemoptysis † 1     
# participants affected / at risk   22/313 (7.03%)   14/313 (4.47%) 
Wheezing † 1     
# participants affected / at risk   17/313 (5.43%)   9/313 (2.88%) 
Dyspnoea Exertional † 1     
# participants affected / at risk   6/313 (1.92%)   17/313 (5.43%) 
Rhinorrhoea † 1     
# participants affected / at risk   16/313 (5.11%)   6/313 (1.92%) 
Skin and subcutaneous tissue disorders     
Rash † 1     
# participants affected / at risk   193/313 (61.66%)   184/313 (58.79%) 
Dry Skin † 1     
# participants affected / at risk   63/313 (20.13%)   58/313 (18.53%) 
Dermatitis Acneiform † 1     
# participants affected / at risk   58/313 (18.53%)   42/313 (13.42%) 
Pruritus † 1     
# participants affected / at risk   47/313 (15.02%)   40/313 (12.78%) 
Alopecia † 1     
# participants affected / at risk   18/313 (5.75%)   16/313 (5.11%) 
Erythema † 1     
# participants affected / at risk   16/313 (5.11%)   11/313 (3.51%) 
Skin Exfoliation † 1     
# participants affected / at risk   8/313 (2.56%)   16/313 (5.11%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   77/313 (24.60%)   26/313 (8.31%) 
Events were collected by systematic assessment
1 Term from vocabulary, MeDRA



  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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