Trial Outcomes & Findings for Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer (NCT NCT00741988)
NCT ID: NCT00741988
Last Updated: 2021-12-15
Results Overview
The Percentage of Patients Who Experience an Objective Benefit From Treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
18 months
Results posted on
2021-12-15
Participant Flow
Participant milestones
| Measure |
Ixabepilone/Carboplatin
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Ixabepilone/Carboplatin
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
Baseline Characteristics
Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone/Carboplatin
n=42 Participants
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
n=40 Participants
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsThe Percentage of Patients Who Experience an Objective Benefit From Treatment
Outcome measures
| Measure |
Ixabepilone/Carboplatin
n=38 Participants
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
n=36 Participants
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
|---|---|---|
|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
29 percentage of participants
Interval 16.0 to 45.0
|
50 percentage of participants
Interval 34.0 to 66.0
|
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Ixabepilone/Carboplatin
n=42 Participants
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
n=40 Participants
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
|---|---|---|
|
Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease
|
5.3 months
Interval 2.8 to 8.6
|
6.7 months
Interval 5.1 to 8.4
|
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Ixabepilone/Carboplatin
n=42 Participants
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
n=40 Participants
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
|---|---|---|
|
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
9.3 months
Interval 6.4 to 16.6
|
13.2 months
Interval 8.9 to
Upper limit not reached due to patients remaining on treatment at time of analysis.
|
SECONDARY outcome
Timeframe: 18 monthsNumber of participants experiencing Grade 3 and Grade 4 Treatment-related toxicities are reported here. Toxicities that were occurring \>=5% of total patients are listed. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE version 3.0) of the National Cancer Institute.
Outcome measures
| Measure |
Ixabepilone/Carboplatin
n=42 Participants
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
n=40 Participants
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing Treatment Related Toxicity
Leukopenia
|
6 Participants
|
9 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Anemia
|
4 Participants
|
6 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Neutropenia
|
13 Participants
|
19 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Febrile neutropenia
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Cardiac arrhythmia
|
2 Participants
|
0 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Dehydration
|
3 Participants
|
3 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Diarrhea
|
3 Participants
|
3 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Fatique
|
4 Participants
|
9 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Hyponatremia
|
2 Participants
|
1 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Infection
|
2 Participants
|
8 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Pain (all types)
|
4 Participants
|
11 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Dyspnea
|
4 Participants
|
4 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Thrombocytopenia
|
8 Participants
|
8 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Vomiting
|
0 Participants
|
4 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Hemorrhagic events (all)
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
allergic (HSR)
|
0 Participants
|
2 Participants
|
|
Number of Participants Experiencing Treatment Related Toxicity
Cough
|
0 Participants
|
4 Participants
|
Adverse Events
Ixabepilone/Carboplatin
Serious events: 14 serious events
Other events: 42 other events
Deaths: 0 deaths
Ixabepilone/Carboplatin/Bevacizumab
Serious events: 18 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone/Carboplatin
n=42 participants at risk
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
n=40 participants at risk
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
9.5%
4/42 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
2/42 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Supraventricular arrhythmia - Atrial fibrillation
|
2.4%
1/42 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
2.4%
1/42 • Number of events 1
|
7.5%
3/40 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemorrhage, Pulmonary/Upper Respiratory - Hemoptysis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Seizure
|
4.8%
2/42 • Number of events 2
|
0.00%
0/40
|
|
Nervous system disorders
Neuropathy - Motor
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Infection - NOS
|
0.00%
0/42
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Infection - Renal/Genitourinary
|
0.00%
0/42
|
2.5%
1/40 • Number of events 2
|
|
General disorders
Pain - Abdomen
|
0.00%
0/42
|
5.0%
2/40 • Number of events 2
|
|
Psychiatric disorders
Mental Status
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Infection - Pneumonia
|
2.4%
1/42 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Immune system disorders
Febrile Neutropenia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Neurology - Neurotoxicity
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Bronchitis
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Surgical and medical procedures
Wound Complication
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Perforation, GI
|
0.00%
0/42
|
5.0%
2/40 • Number of events 2
|
|
Immune system disorders
Neutrophils
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/42
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Pericardial Effusion
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.4%
1/42 • Number of events 1
|
0.00%
0/40
|
Other adverse events
| Measure |
Ixabepilone/Carboplatin
n=42 participants at risk
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
Ixabepilone/Carboplatin/Bevacizumab
n=40 participants at risk
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
|
|---|---|---|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
14.3%
6/42 • Number of events 8
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.7%
15/42 • Number of events 52
|
40.0%
16/40 • Number of events 66
|
|
Gastrointestinal disorders
Anorexia
|
31.0%
13/42 • Number of events 37
|
42.5%
17/40 • Number of events 62
|
|
Gastrointestinal disorders
Constipation
|
40.5%
17/42 • Number of events 39
|
35.0%
14/40 • Number of events 46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.5%
17/42 • Number of events 30
|
37.5%
15/40 • Number of events 56
|
|
Gastrointestinal disorders
Dehydration
|
21.4%
9/42 • Number of events 14
|
20.0%
8/40 • Number of events 12
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
12/42 • Number of events 31
|
25.0%
10/40 • Number of events 38
|
|
Nervous system disorders
Dizziness
|
21.4%
9/42 • Number of events 17
|
15.0%
6/40 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.5%
17/42 • Number of events 50
|
45.0%
18/40 • Number of events 56
|
|
Blood and lymphatic system disorders
Edema - Limb
|
0.00%
0/42
|
25.0%
10/40 • Number of events 23
|
|
General disorders
Fatigue
|
73.8%
31/42 • Number of events 125
|
75.0%
30/40 • Number of events 210
|
|
General disorders
Fever
|
0.00%
0/42
|
20.0%
8/40 • Number of events 12
|
|
Blood and lymphatic system disorders
Hemoglobin
|
83.3%
35/42 • Number of events 132
|
75.0%
30/40 • Number of events 172
|
|
Blood and lymphatic system disorders
Hemorrhage - Urinary
|
0.00%
0/42
|
15.0%
6/40 • Number of events 12
|
|
Blood and lymphatic system disorders
Hemorrhage - Nose
|
0.00%
0/42
|
25.0%
10/40 • Number of events 22
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.9%
5/42 • Number of events 11
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
12/42 • Number of events 21
|
12.5%
5/40 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
6/42 • Number of events 8
|
0.00%
0/40
|
|
Cardiac disorders
Hypertension
|
0.00%
0/42
|
12.5%
5/40 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.9%
5/42 • Number of events 6
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.9%
5/42 • Number of events 11
|
15.0%
6/40 • Number of events 16
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/42
|
20.0%
8/40 • Number of events 17
|
|
Cardiac disorders
Hypotension
|
11.9%
5/42 • Number of events 17
|
0.00%
0/40
|
|
Infections and infestations
Infection - NOS
|
33.3%
14/42 • Number of events 30
|
30.0%
12/40 • Number of events 31
|
|
General disorders
Insomnia
|
21.4%
9/42 • Number of events 23
|
30.0%
12/40 • Number of events 31
|
|
Immune system disorders
Leukocytes
|
61.9%
26/42 • Number of events 71
|
70.0%
28/40 • Number of events 78
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
16.7%
7/42 • Number of events 14
|
12.5%
5/40 • Number of events 12
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
0.00%
0/42
|
17.5%
7/40 • Number of events 25
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
0.00%
0/42
|
25.0%
10/40 • Number of events 28
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/42
|
12.5%
5/40 • Number of events 18
|
|
Gastrointestinal disorders
Nausea
|
54.8%
23/42 • Number of events 56
|
57.5%
23/40 • Number of events 64
|
|
Nervous system disorders
Neuropathy - Sensory
|
35.7%
15/42 • Number of events 52
|
40.0%
16/40 • Number of events 91
|
|
Immune system disorders
Neutrophils
|
69.0%
29/42 • Number of events 67
|
70.0%
28/40 • Number of events 64
|
|
General disorders
Pain
|
66.7%
28/42 • Number of events 150
|
77.5%
31/40 • Number of events 232
|
|
Blood and lymphatic system disorders
Platelets
|
54.8%
23/42 • Number of events 61
|
65.0%
26/40 • Number of events 83
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/42
|
32.5%
13/40 • Number of events 35
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
0.00%
0/42
|
17.5%
7/40 • Number of events 15
|
|
Gastrointestinal disorders
Taste Alteration
|
14.3%
6/42 • Number of events 17
|
30.0%
12/40 • Number of events 50
|
|
Cardiac disorders
Supraventricular arrhythmia - Atrial fibrillation
|
11.9%
5/42 • Number of events 6
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
18/42 • Number of events 32
|
40.0%
16/40 • Number of events 39
|
|
Metabolism and nutrition disorders
Weight Loss
|
0.00%
0/42
|
27.5%
11/40 • Number of events 35
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER