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A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00661778
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Drug: Bevacizumab
Drug: Cisplatin
Drug: Docetaxel
Enrollment 50

Recruitment Details  
Pre-assignment Details The data listed in Participant Flow are for discontinuation from treatment, not discontinuation from the study. Data for discontinuation from the study are not available.
Arm/Group Title Bevacizumab + Cisplatin + Docetaxel
Hide Arm/Group Description Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Period Title: Overall Study
Started 50
Completed 0
Not Completed 50
Reason Not Completed
Disease Progression             23
Adverse Event             18
Reason not Specified             6
Protocol Violation             2
Withdrawal of Consent             1
Arm/Group Title Bevacizumab + Cisplatin + Docetaxel
Hide Arm/Group Description Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
Intent-to-treat population: All enrolled participants who received at least 1 treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
58.31  (9.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
12
  24.0%
Male
38
  76.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Time Frame Baseline to the end of the study (up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
Arm/Group Title Bevacizumab + Cisplatin + Docetaxel
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Months
8.95
(6.92 to 9.97)
2.Secondary Outcome
Title Percentage of Participants With an Objective Response
Hide Description An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Time Frame Baseline to the end of the study (up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable population: All participants who received at least 2 treatment cycles, have had all baseline lesions assessed on at least 1 occasion after receiving the 2nd treatment cycle, and have not had any major protocol violations.
Arm/Group Title Bevacizumab + Cisplatin + Docetaxel
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: Percentage of participants
67.39
3.Secondary Outcome
Title Duration of the Objective Response
Hide Description Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Time Frame Baseline to the end of the study (up to 4 years)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from the first dose of study medication until death.
Time Frame Baseline to the end of the study (up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
Arm/Group Title Bevacizumab + Cisplatin + Docetaxel
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 46
Median (95% Confidence Interval)
Unit of Measure: Months
12.74
(9.48 to 17.79)
5.Secondary Outcome
Title 1-year Survival
Hide Description The probability of surviving 1 year was estimated using the Kaplan-Meier method.
Time Frame Baseline to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
Arm/Group Title Bevacizumab + Cisplatin + Docetaxel
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
53.46
(39.19 to 67.45)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
 
Arm/Group Title Bevacizumab + Cisplatin + Docetaxel
Hide Arm/Group Description Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
All-Cause Mortality
Bevacizumab + Cisplatin + Docetaxel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Cisplatin + Docetaxel
Affected / at Risk (%)
Total   26/49 (53.06%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  5/49 (10.20%) 
Cardiac disorders   
Palpitations  1  1/49 (2.04%) 
Myocardial infarction  1  1/49 (2.04%) 
Gastrointestinal disorders   
Diarrhoea  1  2/49 (4.08%) 
Vomiting  1  1/49 (2.04%) 
General disorders   
Pyrexia  1  3/49 (6.12%) 
Mucosal inflammation  1  2/49 (4.08%) 
Reaction at the injection site  1  1/49 (2.04%) 
Asthenia  1  1/49 (2.04%) 
Death  1  1/49 (2.04%) 
Infections and infestations   
Respiratory tract infection  1  2/49 (4.08%) 
Oral candidiasis  1  1/49 (2.04%) 
Anal abscess  1  1/49 (2.04%) 
Infection  1  1/49 (2.04%) 
Pneumonia  1  1/49 (2.04%) 
Injury, poisoning and procedural complications   
Fracture  1  1/49 (2.04%) 
Wound evisceration  1  1/49 (2.04%) 
Investigations   
Neutrophil count increased  1  6/49 (12.24%) 
Positron emission tomography  1  1/49 (2.04%) 
Decreased leukocyte count  1  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  3/49 (6.12%) 
Haemoptysis  1  2/49 (4.08%) 
Pneumothorax  1  1/49 (2.04%) 
Pulmonary embolism  1  1/49 (2.04%) 
Surgical and medical procedures   
Appendectomy  1  1/49 (2.04%) 
Vascular disorders   
Deep vein thrombosis  1  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab + Cisplatin + Docetaxel
Affected / at Risk (%)
Total   48/49 (97.96%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  5/49 (10.20%) 
Lymphopenia  1  2/49 (4.08%) 
Bone marrow depression  1  1/49 (2.04%) 
Cardiac disorders   
Palpitations  1  1/49 (2.04%) 
Tachycardia  1  1/49 (2.04%) 
Myocardial infarction  1  1/49 (2.04%) 
Ear and labyrinth disorders   
Tinnitus  1  1/49 (2.04%) 
Endocrine disorders   
Hypothyroidism  1  1/49 (2.04%) 
Eye disorders   
Increased lacrimation  1  1/49 (2.04%) 
Conjunctivitis  1  1/49 (2.04%) 
Gastrointestinal disorders   
Diarrhoea  1  27/49 (55.10%) 
Nausea  1  19/49 (38.78%) 
Vomiting  1  18/49 (36.73%) 
Constipation  1  11/49 (22.45%) 
Dry mouth  1  8/49 (16.33%) 
Abdominal pain  1  4/49 (8.16%) 
Odynophagia  1  2/49 (4.08%) 
Oesophagitis  1  2/49 (4.08%) 
Rectal bleeding  1  2/49 (4.08%) 
Flatulence  1  1/49 (2.04%) 
Dysphagia  1  1/49 (2.04%) 
Retching  1  1/49 (2.04%) 
Hematemesis  1  1/49 (2.04%) 
Hemorrhoids  1  1/49 (2.04%) 
Gingival bleeding  1  1/49 (2.04%) 
Proctalgia  1  1/49 (2.04%) 
Abdominal distension  1  1/49 (2.04%) 
Aphthous stomatitis  1  1/49 (2.04%) 
General disorders   
Fatigue  1  36/49 (73.47%) 
Mucosal inflammation  1  21/49 (42.86%) 
Pyrexia  1  15/49 (30.61%) 
Pain  1  6/49 (12.24%) 
Asthenia  1  3/49 (6.12%) 
Edema  1  2/49 (4.08%) 
Reaction at the injection site  1  2/49 (4.08%) 
Peripheral edema  1  2/49 (4.08%) 
Chest pain  1  2/49 (4.08%) 
Extravasation  1  1/49 (2.04%) 
Death  1  1/49 (2.04%) 
Infections and infestations   
Respiratory tract infection  1  5/49 (10.20%) 
Infection  1  3/49 (6.12%) 
Respiratory tract infection  1  2/49 (4.08%) 
Pneumonia  1  2/49 (4.08%) 
Oral candidiasis  1  1/49 (2.04%) 
Tooth infection  1  1/49 (2.04%) 
Furuncle  1  1/49 (2.04%) 
Parotiditis  1  1/49 (2.04%) 
Oral infection  1  1/49 (2.04%) 
Upper respiratory tract infection  1  1/49 (2.04%) 
Anal abscess  1  1/49 (2.04%) 
Injury, poisoning and procedural complications   
Fracture  1  1/49 (2.04%) 
Wound evisceration  1  1/49 (2.04%) 
Investigations   
Decreased hemoglobin  1  21/49 (42.86%) 
High neutrophil count  1  14/49 (28.57%) 
Decreased platelet count  1  11/49 (22.45%) 
Elevated blood creatinine  1  10/49 (20.41%) 
Decreased leukocyte count  1  9/49 (18.37%) 
Gamma glutamyltransferase  1  7/49 (14.29%) 
Elevated alanine aminotransferase  1  4/49 (8.16%) 
Decreased total protein  1  3/49 (6.12%) 
Decreased lymphocyte count  1  3/49 (6.12%) 
Abnormal transaminases  1  3/49 (6.12%) 
Elevated blood urea  1  3/49 (6.12%) 
Urinary urobilin  1  2/49 (4.08%) 
Decreased neutrophil count  1  2/49 (4.08%) 
Elevated leukocyte count  1  2/49 (4.08%) 
Increased blood alkaline phosphatase  1  2/49 (4.08%) 
Elevated gamma glutamyl transferase  1  2/49 (4.08%) 
Elevated blood lactate dehydrogenase  1  2/49 (4.08%) 
Elevated blood bilirubin  1  2/49 (4.08%) 
Blood urea  1  1/49 (2.04%) 
Decreased monocyte count  1  1/49 (2.04%) 
Hipofonesis  1  1/49 (2.04%) 
Elevated triglycerides in blood  1  1/49 (2.04%) 
Elevated ferritin in serum  1  1/49 (2.04%) 
Positron emission tomography  1  1/49 (2.04%) 
Alanine aminotransferase  1  1/49 (2.04%) 
Abnormal coagulation test  1  1/49 (2.04%) 
Increased international normalised ratio  1  1/49 (2.04%) 
Prolonged activated partial thromboplastin time  1  1/49 (2.04%) 
Decreased blood creatinine  1  1/49 (2.04%) 
Decreased calcium in blood  1  1/49 (2.04%) 
White blood count  1  1/49 (2.04%) 
Lymphocyte count  1  1/49 (2.04%) 
Elevated aspartate aminotransferase  1  1/49 (2.04%) 
Metabolism and nutrition disorders   
Hyperuricemia  1  1/49 (2.04%) 
Anorexia  1  17/49 (34.69%) 
Hyperglycemia  1  11/49 (22.45%) 
Hyponatremia  1  7/49 (14.29%) 
Hypercholesterolemia  1  5/49 (10.20%) 
Hyperpotassemia  1  5/49 (10.20%) 
Hypoalbuminemia  1  4/49 (8.16%) 
Hypercalcemia  1  2/49 (4.08%) 
Hypertriglyceridemia  1  2/49 (4.08%) 
Hypocalcemia  1  1/49 (2.04%) 
Dehydration  1  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders   
Hypokalemia  1  5/49 (10.20%) 
Arthralgia  1  5/49 (10.20%) 
Myalgia  1  4/49 (8.16%) 
Back pain  1  3/49 (6.12%) 
Bone pain  1  2/49 (4.08%) 
Musculoskeletal pain  1  2/49 (4.08%) 
Shoulder pain  1  1/49 (2.04%) 
Pain in one extremity  1  1/49 (2.04%) 
Pain in the chest wall  1  1/49 (2.04%) 
Pain in sacrum  1  1/49 (2.04%) 
Fistula  1  1/49 (2.04%) 
Nervous system disorders   
Neuropathy  1  13/49 (26.53%) 
Dysgeusia  1  2/49 (4.08%) 
Headache  1  1/49 (2.04%) 
Paresthesia  1  1/49 (2.04%) 
Syncope  1  1/49 (2.04%) 
Decreased consciousness  1  1/49 (2.04%) 
Dizziness  1  1/49 (2.04%) 
Psychiatric disorders   
Anxiety  1  4/49 (8.16%) 
Depression  1  3/49 (6.12%) 
Disorientation  1  1/49 (2.04%) 
Renal and urinary disorders   
Proteinuria  1  7/49 (14.29%) 
Hematuria  1  1/49 (2.04%) 
Reproductive system and breast disorders   
Amenorrhea  1  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  19/49 (38.78%) 
Dyspnea  1  10/49 (20.41%) 
Cough  1  4/49 (8.16%) 
Haemoptysis  1  3/49 (6.12%) 
Dysphonia  1  3/49 (6.12%) 
Hypoxia  1  1/49 (2.04%) 
Perforation of the nasal septum  1  1/49 (2.04%) 
Hiccupping  1  1/49 (2.04%) 
Orthopnea  1  1/49 (2.04%) 
Pleuritic pain  1  1/49 (2.04%) 
Pneumothorax  1  1/49 (2.04%) 
Pulmonary embolism  1  1/49 (2.04%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  22/49 (44.90%) 
Onycholysis  1  3/49 (6.12%) 
Ungueal toxicity  1  2/49 (4.08%) 
Rash  1  2/49 (4.08%) 
Generalised erythema  1  1/49 (2.04%) 
Erythrodermic psoriasis  1  1/49 (2.04%) 
Cutaneous toxicity  1  1/49 (2.04%) 
Erythema  1  1/49 (2.04%) 
Hyperpigmentation of the skin  1  1/49 (2.04%) 
Hirsutism  1  1/49 (2.04%) 
Pigmentation disorder  1  1/49 (2.04%) 
Pruritus  1  1/49 (2.04%) 
Dermatitis acneiform  1  1/49 (2.04%) 
Surgical and medical procedures   
Appendectomy  1  1/49 (2.04%) 
Vascular disorders   
Hypertension  1  8/49 (16.33%) 
Phlebitis  1  4/49 (8.16%) 
Deep vein thrombosis  1  2/49 (4.08%) 
Hypotension  1  1/49 (2.04%) 
Flushing  1  1/49 (2.04%) 
Haemorrhage  1  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661778     History of Changes
Other Study ID Numbers: ML20081
2006-005619-88 ( EudraCT Number )
First Submitted: April 17, 2008
First Posted: April 18, 2008
Results First Submitted: May 27, 2014
Results First Posted: July 10, 2014
Last Update Posted: July 10, 2014