Trial Outcomes & Findings for Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer (NCT NCT00118144)
NCT ID: NCT00118144
Last Updated: 2014-08-21
Results Overview
A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2014-08-21
Participant Flow
Participant milestones
| Measure |
Arm I
Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=42 Participants
Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsA response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.
Outcome measures
| Measure |
Arm 1
n=42 Participants
Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
|
|---|---|
|
Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.
|
5 percentage of responders
|
SECONDARY outcome
Timeframe: Up to 5 yearsProgression Free Survival using the product-limit method of Kaplan and Meier
Outcome measures
| Measure |
Arm 1
n=42 Participants
Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
|
|---|---|
|
Progression-free Survival
|
5.5 Months
Interval 2.1 to 6.4
|
SECONDARY outcome
Timeframe: Up to 5 yearsOverall Suvival using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Arm 1
n=42 Participants
Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
|
|---|---|
|
Overall Survival
|
13.6 Months
Interval 4.97 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
Adverse Events
Arm I
Serious events: 12 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=42 participants at risk
Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
2/42 • Number of events 2
|
|
General disorders
Disease progression
|
9.5%
4/42 • Number of events 4
|
|
General disorders
Fatigue
|
4.8%
2/42 • Number of events 2
|
|
General disorders
Fever
|
2.4%
1/42 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Bilirubin increased
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
2/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
3/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Arm I
n=42 participants at risk
Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
35.7%
15/42 • Number of events 92
|
|
Blood and lymphatic system disorders
Lymphangiopathy NOS
|
2.4%
1/42 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
2/42 • Number of events 4
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.4%
1/42 • Number of events 1
|
|
Endocrine disorders
Endocrine disorder
|
2.4%
1/42 • Number of events 1
|
|
Eye disorders
Cataract
|
2.4%
1/42 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
2.4%
1/42 • Number of events 2
|
|
Eye disorders
Flashing vision
|
2.4%
1/42 • Number of events 3
|
|
Eye disorders
Vision blurred
|
7.1%
3/42 • Number of events 9
|
|
Eye disorders
Watering eyes
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
2/42 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
8/42 • Number of events 13
|
|
Gastrointestinal disorders
Constipation
|
33.3%
14/42 • Number of events 42
|
|
Gastrointestinal disorders
Diarrhea
|
47.6%
20/42 • Number of events 51
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
3/42 • Number of events 5
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
52.4%
22/42 • Number of events 48
|
|
Gastrointestinal disorders
Stomach pain
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Tooth disorder
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
4.8%
2/42 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
11/42 • Number of events 18
|
|
General disorders
Chest pain
|
16.7%
7/42 • Number of events 16
|
|
General disorders
Chills
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Death
|
7.1%
3/42 • Number of events 3
|
|
General disorders
Disease progression
|
35.7%
15/42 • Number of events 15
|
|
General disorders
Edema limbs
|
9.5%
4/42 • Number of events 5
|
|
General disorders
Fatigue
|
69.0%
29/42 • Number of events 146
|
|
General disorders
Fever
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Flu-like symptoms
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Ill-defined disorder
|
4.8%
2/42 • Number of events 3
|
|
General disorders
Pain
|
14.3%
6/42 • Number of events 7
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
2.4%
1/42 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
4.8%
2/42 • Number of events 6
|
|
Infections and infestations
Conjunctivitis infective
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Lip infection
|
4.8%
2/42 • Number of events 3
|
|
Infections and infestations
Otitis externa
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Peripheral nerve infection
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
2.4%
1/42 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
4.8%
2/42 • Number of events 3
|
|
Infections and infestations
Upper aerodigestive tract infection
|
4.8%
2/42 • Number of events 3
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
2/42 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bruising
|
2.4%
1/42 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
1/42 • Number of events 4
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
4/42 • Number of events 12
|
|
Investigations
Alkaline phosphatase increased
|
11.9%
5/42 • Number of events 15
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
4/42 • Number of events 13
|
|
Investigations
Bilirubin increased
|
2.4%
1/42 • Number of events 2
|
|
Investigations
Creatinine increased
|
4.8%
2/42 • Number of events 3
|
|
Investigations
Hyperbilirubinemia
|
2.4%
1/42 • Number of events 3
|
|
Investigations
INR increased
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
4.8%
2/42 • Number of events 11
|
|
Investigations
Leukopenia
|
7.1%
3/42 • Number of events 25
|
|
Investigations
Lipase increased
|
2.4%
1/42 • Number of events 3
|
|
Investigations
Lymphocyte count decreased
|
21.4%
9/42 • Number of events 9
|
|
Investigations
Lymphopenia
|
7.1%
3/42 • Number of events 7
|
|
Investigations
Neutrophil count decreased
|
14.3%
6/42 • Number of events 28
|
|
Investigations
Platelet count decreased
|
14.3%
6/42 • Number of events 17
|
|
Investigations
Serum cholesterol increased
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Weight loss
|
4.8%
2/42 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
14/42 • Number of events 26
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
23.8%
10/42 • Number of events 28
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
3/42 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
6/42 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
3/42 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
2/42 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.8%
2/42 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
1/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
2/42 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
11.9%
5/42 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
14.3%
6/42 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
7.1%
3/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.8%
2/42 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
7.1%
3/42 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
9.5%
4/42 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
16.7%
7/42 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.4%
1/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
2.4%
1/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
4/42 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
3/42 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.5%
4/42 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
28.6%
12/42 • Number of events 30
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
7.1%
3/42 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
4.8%
2/42 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.8%
10/42 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.0%
8/42 • Number of events 10
|
|
Nervous system disorders
Ataxia
|
2.4%
1/42 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
14.3%
6/42 • Number of events 18
|
|
Nervous system disorders
Headache
|
26.2%
11/42 • Number of events 33
|
|
Nervous system disorders
Memory impairment
|
4.8%
2/42 • Number of events 3
|
|
Nervous system disorders
Neuralgia
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.8%
2/42 • Number of events 7
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
42.9%
18/42 • Number of events 66
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
2.4%
1/42 • Number of events 3
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
7.1%
3/42 • Number of events 6
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Depression
|
9.5%
4/42 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
11.9%
5/42 • Number of events 18
|
|
Renal and urinary disorders
Protein urine positive
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.9%
5/42 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.1%
3/42 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.0%
13/42 • Number of events 42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
18/42 • Number of events 51
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
2.4%
1/42 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.4%
1/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.4%
1/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.4%
1/42 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.4%
1/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
3/42 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.9%
5/42 • Number of events 27
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.8%
2/42 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
16.7%
7/42 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.4%
1/42 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
7.1%
3/42 • Number of events 15
|
|
Vascular disorders
Flushing
|
4.8%
2/42 • Number of events 2
|
|
Vascular disorders
Hematoma
|
2.4%
1/42 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
2.4%
1/42 • Number of events 6
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
Hypotension
|
7.1%
3/42 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60