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Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00541099
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : August 21, 2014
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Biological: bevacizumab
Drug: docetaxel
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Avastin & Docetaxel
Hide Arm/Group Description

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

bevacizumab: Avastin 10.0 mg/kg on days 1 and 15

docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Period Title: Overall Study
Started 11
Completed 8
Not Completed 3
Reason Not Completed
Ineligible             3
Arm/Group Title Avastin & Docetaxel
Hide Arm/Group Description

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

bevacizumab: Avastin 10.0 mg/kg on days 1 and 15

docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
79.7  (4.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Survival
Hide Description [Not Specified]
Time Frame 6 months when treated with combination of Avastin and weekly docetaxel
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avastin & Docetaxel
Hide Arm/Group Description:

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

bevacizumab: Avastin 10.0 mg/kg on days 1 and 15

docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Overall Number of Participants Analyzed 8
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants surviving
75
(40 to 95)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival in months via the Kaplan-Meier method
Time Frame 6 months when treated with combination of Avastin and weekly docetaxel
Hide Outcome Measure Data
Hide Analysis Population Description
No patient showed a response, therefore all patients had 0 for PFS
Arm/Group Title Avastin & Docetaxel
Hide Arm/Group Description:

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

bevacizumab: Avastin 10.0 mg/kg on days 1 and 15

docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival using Kaplan-Meier method.
Time Frame 4 weeks after removal from study or until death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avastin & Docetaxel
Hide Arm/Group Description:

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

bevacizumab: Avastin 10.0 mg/kg on days 1 and 15

docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: months
35.7
(1.7 to 41.3)
4.Secondary Outcome
Title Response Rate
Hide Description [Not Specified]
Time Frame Every 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avastin & Docetaxel
Hide Arm/Group Description:

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

bevacizumab: Avastin 10.0 mg/kg on days 1 and 15

docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Hide Description Toxicity: using the highest grade of each toxicity experienced by each patient according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame 1st and 2nd week of each 21 day cycle, up to six cycles.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avastin & Docetaxel
Hide Arm/Group Description:

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

bevacizumab: Avastin 10.0 mg/kg on days 1 and 15

docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Adverse event
Serious (grade 3 or 4) 21
other (grade 0, 1, or 2) 123
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Avastin & Docetaxel
Hide Arm/Group Description

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

bevacizumab: Avastin 10.0 mg/kg on days 1 and 15

docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

All-Cause Mortality
Avastin & Docetaxel
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Avastin & Docetaxel
Affected / at Risk (%) # Events
Total   3/8 (37.50%)    
Blood and lymphatic system disorders   
Decreased ANC  1  1/8 (12.50%)  1
Decreased WBC  1  1/8 (12.50%)  1
Lymphopenia  1  2/8 (25.00%)  5
Cardiac disorders   
Hypertension  1  1/8 (12.50%)  1
Gastrointestinal disorders   
Diarrhea  1  3/8 (37.50%)  4
Perineal abscess  1  1/8 (12.50%)  1
General disorders   
Fatigue  1  2/8 (25.00%)  2
Metabolism and nutrition disorders   
Hyperglycemia  1  3/8 (37.50%)  8
Proteinuria  1  1/8 (12.50%)  1
Musculoskeletal and connective tissue disorders   
Generalized Muscle Weakness  1  1/8 (12.50%)  1
Nervous system disorders   
Syncope  1  1/8 (12.50%)  1
Renal and urinary disorders   
Urosepsis  1  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
dyspnea  1  2/8 (25.00%)  2
Pleural Effusion  1  1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Avastin & Docetaxel
Affected / at Risk (%) # Events
Total   6/8 (75.00%)    
Blood and lymphatic system disorders   
Leukocytes  1  1/8 (12.50%)  1
Neutropenia  1  1/8 (12.50%)  1
Thrombocytopenia  1  1/8 (12.50%)  1
Leukpenia  1  1/8 (12.50%)  2
Cardiac disorders   
Pericardial Effusion  1  1/8 (12.50%)  1
Eye disorders   
Eye Tearing  1  1/8 (12.50%)  1
Lacrimation  1  1/8 (12.50%)  1
Tearing in eyes  1  1/8 (12.50%)  2
Watery Eye  1  1/8 (12.50%)  1
Gastrointestinal disorders   
Acute Colitis  1  1/8 (12.50%)  1
Diarrhea  1  6/8 (75.00%)  19
Metallic taste  1  1/8 (12.50%)  1
Mucositis  1  1/8 (12.50%)  1
Nausea  1  2/8 (25.00%)  3
Oral Thrush  1  1/8 (12.50%)  1
Taste Alteration  1  4/8 (50.00%)  6
Vomiting  1  1/8 (12.50%)  3
Edema: limbs  1  1/8 (12.50%)  1
Edema: trunk/genital  1  1/8 (12.50%)  1
General disorders   
Chills  1  1/8 (12.50%)  1
Fatigue  1  6/8 (75.00%)  16
Pain: Chest/Torax NOS  1  1/8 (12.50%)  2
R. Arm Extravasation  1  1/8 (12.50%)  1
Arm Laceration  1  1/8 (12.50%)  1
Decubitus  1  1/8 (12.50%)  2
Immune system disorders   
Allergic Reaction  1  1/8 (12.50%)  2
Infections and infestations   
UTI  1  3/8 (37.50%)  3
Urinary Tract Infection  1  1/8 (12.50%)  1
Injury, poisoning and procedural complications   
Bruising  1  1/8 (12.50%)  1
Fracture  1  1/8 (12.50%)  2
pain: Trauma site  1  1/8 (12.50%)  1
R. Elbow-Soft Tissue Trauma  1  1/8 (12.50%)  3
Investigations   
Alkaline Phosphatase  1  1/8 (12.50%)  1
Decreased HgB  1  2/8 (25.00%)  7
Decreased WBC  1  3/8 (37.50%)  6
Hemoglobin  1  1/8 (12.50%)  5
Increased Creatinine  1  1/8 (12.50%)  2
Lymphopenia  1  1/8 (12.50%)  6
Weight Loss  1  2/8 (25.00%)  5
Metabolism and nutrition disorders   
Anorexia  1  4/8 (50.00%)  6
Dehydration  1  3/8 (37.50%)  3
Hypercalcemia  1  1/8 (12.50%)  1
Hyperglycemia  1  2/8 (25.00%)  8
Hyperkalemia  1  1/8 (12.50%)  3
Hypoalbuminemia  1  5/8 (62.50%)  15
Hyponatremia  1  1/8 (12.50%)  2
Musculoskeletal and connective tissue disorders   
Back pain  1  1/8 (12.50%)  1
Bilateral Leg Pain  1  1/8 (12.50%)  1
Generalized muscle weakness  1  1/8 (12.50%)  5
Lower Back Pain  1  1/8 (12.50%)  1
Nervous system disorders   
Dizziness  1  1/8 (12.50%)  1
Sensory Neuropathy  1  2/8 (25.00%)  2
Vasovagal episode  1  1/8 (12.50%)  2
Psychiatric disorders   
Insomina  1  1/8 (12.50%)  1
Renal and urinary disorders   
Proteinuria  1  3/8 (37.50%)  7
Urinary Frequency  1  1/8 (12.50%)  2
Reproductive system and breast disorders   
Sinus Congest  1  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/8 (37.50%)  3
Dyspnea  1  1/8 (12.50%)  3
epistaxis  1  2/8 (25.00%)  2
Hypoxia  1  1/8 (12.50%)  1
Nose Bleed  1  3/8 (37.50%)  3
Pleural effusion  1  2/8 (25.00%)  3
Sinus Drainage  1  1/8 (12.50%)  1
Sore Throat  1  1/8 (12.50%)  1
upper resp infection  1  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Brittle Nails  1  1/8 (12.50%)  2
Alopecia  1  4/8 (50.00%)  5
Chest Wall Rash  1  1/8 (12.50%)  1
Dry Skin  1  1/8 (12.50%)  2
Hyperpigmentation  1  1/8 (12.50%)  2
Nail Changes  1  2/8 (25.00%)  2
Pruritis  1  1/8 (12.50%)  2
Skin peeling-hands  1  1/8 (12.50%)  1
Vascular disorders   
Flushing  1  1/8 (12.50%)  1
HTN  1  1/8 (12.50%)  1
Hypotension  1  1/8 (12.50%)  1
Hypertension  1  3/8 (37.50%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
The increased use of pemetrexed in the front line setting affected accrual.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shirish Gadgeel, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: (313) 576-8753
EMail: sgadgeel@med.umich.edu
Layout table for additonal information
Responsible Party: Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00541099    
Obsolete Identifiers: NCT01665443
Other Study ID Numbers: CDR0000555019
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2007-053
First Submitted: October 5, 2007
First Posted: October 8, 2007
Results First Submitted: August 5, 2014
Results First Posted: August 21, 2014
Last Update Posted: March 27, 2019