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Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00323869
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : July 27, 2016
Last Update Posted : September 7, 2016
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
Heather Wakelee, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lung Cancer
Non-small Cell Lung Cancer (NSCLC)
Interventions Drug: Bevacizumab
Drug: Gemcitabine
Drug: Carboplatin
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description

Bevacizumab in combination with carboplatin and gemcitabine

Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity Gemcitabine, administered 1000 mg/m2 IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles

Carboplatin was administered before gemcitabine infusion.

Bevacizumab was administered 1 hour after end of all chemotherapy infusions.

Bevacizumab: Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody

Gemcitabine: Nucleoside analog

Carboplatin: Alkylating agent

Period Title: Overall Study
Started 48 [1]
Treatment Initiation 47 [2]
Completed 47
Not Completed 1
Reason Not Completed
Death             1
[1]
Enrollment
[2]
One participant died before receiving therapy, not included in analysis
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 47 participants
59
(35 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
25
  53.2%
Male
22
  46.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Hispanic or Latino
3
   6.4%
Not Hispanic or Latino
42
  89.4%
Unknown or Not Reported
2
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
American Indian or Alaska Native
1
   2.1%
Asian
10
  21.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   6.4%
White
29
  61.7%
More than one race
0
   0.0%
Unknown or Not Reported
4
   8.5%
Eastern Cooperative Oncology Group (ECOG) performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
ECOG 0 3
ECOG 1 44
[1]
Measure Description:

ECOG performance status

  • 0 = Fully active, able to carry on all pre-disease performance without restriction
  • 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work
  • 2 = Unable to work, must sit or lie > 50% waking hours
  • 3 = Capable of limited selfcare; confined to bed or chair > 50% waking hours
  • 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed/chair
  • 5 = Deceased
Smoking Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
Never a smoker 19
Has stopped smoking (ex-smoker) 7
Currently a smoker 21
[1]
Measure Description:

Smoking status based on self-declaration between:

  • Never a smoker (< 100 cigarettes in lifetime)
  • Quit and not currently a smoker
  • Currently a smoker.
Non-small Cell Lung Cancer (NSCLC) Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
Adenocarcinoma 30
Bronchioloalveolar carcinoma (BAC) 4
NSCLC not otherwise specified 13
Non-small Cell Lung Cancer Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
NSCLC Stage III-B 8
NSCLC Stage IV 39
[1]
Measure Description: During the time of the trial patients with a malignant pleural effusion as only site of metastases were considered stage III-B (AJCC 6th edition). They were treated the same as stage IV (metastatic). Thus all patients included in this trial had advanced stage NSCLC and if staged under current staging criteria (AJCC 7th edition) all would be considered stage IV (metastatic).
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Median (Full Range)
Unit of Measure: months
8.7
(7.8 to 17.9)
2.Secondary Outcome
Title Response Rate (CR + PR + SD)
Hide Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE

Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.

  • Complete Response (CR) = disappearance of all target lesions
  • Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions
  • Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions
  • Stable Disease (SD): No significant effect, does not meet criteria for PR or PD.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
41
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description To evaluate the safety of the combination regimen.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
12.8
(10.0 to 16.5)
4.Secondary Outcome
Title Partial Response (PR)
Hide Description Number of subjects with PR per RECIST criteria
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
7
5.Secondary Outcome
Title Complete Response (CR)
Hide Description Number of subjects with CR per RECIST criteria
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Stable Disease (SD)
Hide Description Number of subjects with SD per RECIST criteria
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
34
7.Secondary Outcome
Title Time-to-First Event
Hide Description Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
6.4
(4.8 to 7.9)
8.Secondary Outcome
Title Overall Survival (OS) at 12 Months
Hide Description Number of subjects surviving 1 year after treatment initiation
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
27
9.Secondary Outcome
Title Overall Survival (OS) at 24 Months
Hide Description Number of subjects surviving 2 years after treatment initiation
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who initiated treatment
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description:

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
5
Time Frame 6 weeks
Adverse Event Reporting Description All assessments were taken after every two cycles. Evaluations were taken the first 6 weeks, then every 3 weeks
 
Arm/Group Title Bevacizumab + Carboplatin + Gemcitabine
Hide Arm/Group Description

Treatment provided in 3-week cycles:

  • 15 mg/kg bevacizumab Day 1 of each cycle
  • 1000 mg/m2 gemcitabine Days 1 and 8 of each cycle
  • Carboplatin (AUC of 5 every 3 weeks)
All-Cause Mortality
Bevacizumab + Carboplatin + Gemcitabine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Bevacizumab + Carboplatin + Gemcitabine
Affected / at Risk (%) # Events
Total   28/47 (59.57%)    
Blood and lymphatic system disorders   
Anemia  1  2/47 (4.26%)  2
Neutropenia  1  1/47 (2.13%)  1
Thrombocytopenia  1  4/47 (8.51%)  4
Hemorrahage  1 [1]  1/47 (2.13%)  1
Platetes  1  1/47 (2.13%)  1
Hypotension  1  1/47 (2.13%)  1
Leukocytes  1  1/47 (2.13%)  1
Hematoma  1 [2]  1/47 (2.13%)  1
General disorders   
Death  1  1/47 (2.13%)  1
Pain  1  3/47 (6.38%)  3
Metabolism and nutrition disorders   
Hyponatreamia due to SIADH  1 [3]  1/47 (2.13%)  1
Bilirubin  1 [4]  1/47 (2.13%)  1
Nervous system disorders   
Confusion  1  1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  2/47 (4.26%)  2
Hemoptysis  1  2/47 (4.26%)  2
Dyspnea  1  3/47 (6.38%)  3
Cough  1 [5]  1/47 (2.13%)  1
Pulmonary Respiratory Distress  1  1/47 (2.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Nose
[2]
Liver Hemorrhage
[3]
SIADH- syndrome of inappropriate antidiuretic hormone
[4]
hyperbilirubinemia
[5]
Possible Pneumonia
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab + Carboplatin + Gemcitabine
Affected / at Risk (%) # Events
Total   17/47 (36.17%)    
Blood and lymphatic system disorders   
Neutropenia  1  4/47 (8.51%)  6
Thrombocytopenia  1  1/47 (2.13%)  1
Anemia  1  2/47 (4.26%)  2
Leukocytes  1  3/47 (6.38%)  3
Neutrophilis/Granolocytes  1  1/47 (2.13%)  1
Creatinine  1  1/47 (2.13%)  1
Cardiac disorders   
Pain  1 [1]  1/47 (2.13%)  1
Infections and infestations   
Infection  1  1/47 (2.13%)  1
Metabolism and nutrition disorders   
Transaminitis  1  1/47 (2.13%)  1
Nervous system disorders   
Confusion  1  2/47 (4.26%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Chest
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: Heather A Wakelee, MD, Associate Professor of Medicine (Oncology)
Organization: Stanford University Medical Center
Phone: 650-498-6000
EMail: hwakelee@stanford.edu
Layout table for additonal information
Responsible Party: Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier: NCT00323869    
Other Study ID Numbers: IRB-03730
96655 ( Other Identifier: Stanford IRB alternate number )
AVF3576s
LUN0013 ( Other Identifier: OnCore )
First Submitted: May 8, 2006
First Posted: May 10, 2006
Results First Submitted: April 20, 2016
Results First Posted: July 27, 2016
Last Update Posted: September 7, 2016