Trial Outcomes & Findings for Cediranib, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00795340)
NCT ID: NCT00795340
Last Updated: 2023-08-22
Results Overview
Medians of survival time, and their confidence intervals.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
306 participants
Primary outcome timeframe
at every 3 months visit throughout trial, a median of 13.1 months.
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
Cediranib
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV
|
Placebo
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
153
|
|
Overall Study
COMPLETED
|
146
|
153
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cediranib, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cediranib
n=153 Participants
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV
|
Placebo
n=153 Participants
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
129 participants
n=5 Participants
|
132 participants
n=7 Participants
|
261 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aboriginal
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
102 participants
n=5 Participants
|
98 participants
n=7 Participants
|
200 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
44 participants
n=5 Participants
|
44 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
PRIMARY outcome
Timeframe: at every 3 months visit throughout trial, a median of 13.1 months.Population: ITT
Medians of survival time, and their confidence intervals.
Outcome measures
| Measure |
Cediranib
n=153 Participants
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV
|
Placebo
n=153 Participants
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
|
|---|---|---|
|
Overall Survival
|
12.2 months
Interval 9.1 to 18.0
|
12.1 months
Interval 11.1 to 15.5
|
SECONDARY outcome
Timeframe: at every 3 months visit throughout trial, a median of 12 monthsPopulation: ITT
Medians of PFS and their confidence intervals by arm
Outcome measures
| Measure |
Cediranib
n=153 Participants
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV
|
Placebo
n=153 Participants
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
|
|---|---|---|
|
Progression-free Survival
|
5.52 months
Interval 4.86 to 6.05
|
5.45 months
Interval 4.86 to 5.78
|
SECONDARY outcome
Timeframe: Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.Population: ITT
Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.
Outcome measures
| Measure |
Cediranib
n=153 Participants
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
carboplatin: Given IV
cediranib maleate: Given orally
paclitaxel: Given IV
|
Placebo
n=153 Participants
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
carboplatin: Given IV
paclitaxel: Given IV
placebo: Given orally
|
|---|---|---|
|
Objective Tumor Response as Assessed by RECIST Criteria v1.1.
|
52 percentage of participants
Interval 44.0 to 60.0
|
34 percentage of participants
Interval 26.0 to 42.0
|
Adverse Events
Cediranib
Serious events: 67 serious events
Other events: 151 other events
Deaths: 0 deaths
Placebo
Serious events: 54 serious events
Other events: 152 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cediranib
n=153 participants at risk
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
|
Placebo
n=153 participants at risk
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Cardiac disorders
Supraventricular arrhythmia Atrial fibrillation
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Cardiac disorders
Supraventricular arrhythmia Sinus tachycardia
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Eye disorders
Blurred vision
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) Oral cavity
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
6/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Obstruction, GI Small bowel NOS
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Pain Abdomen NOS
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Perforation, GI Colon
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Death Death NOS
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Death Disease progression NOS
|
3.9%
6/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.6%
4/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Edema: limb
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Fatigue
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Fever
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Pain Chest/thorax NOS
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.6%
4/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Hepatobiliary disorders
Pain Liver
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Colitis, infectious
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection (documented clinically) Blood
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection (documented clinically) Colon
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection (documented clinically) Lung
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection (documented clinically) Meninges
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection (documented clinically) Skin
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection (documented clinically) Upper airway NOS
|
2.6%
4/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Abdomen NOS
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Anal/perianal
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Bladder
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Colon
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Larynx
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Lung
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access)
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Investigations
Neutrophils
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.6%
4/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Investigations
Platelets
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Investigations
cTnI
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Extremity-lower
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Whole body/generalized
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Back
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Bone
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Extremity-limb
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Muscle
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain Tumor pain
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
CNS hemorrhage
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
CNS ischemia
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Neuropathy: cranial CN VIII
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Pain Head/headache
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Seizure
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Somnolence
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Psychiatric disorders
Confusion
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Renal and urinary disorders
Hemorrhage, GU Urinary NOS
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary Lung
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Vascular disorders
Hemorrhage - Other
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.00%
0/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Vascular disorders
Hypotension
|
1.3%
2/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.6%
4/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.8%
12/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
Other adverse events
| Measure |
Cediranib
n=153 participants at risk
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
|
Placebo
n=153 participants at risk
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.5%
13/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Cardiac disorders
Supraventricular arrhythmia Sinus tachycardia
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Ear and labyrinth disorders
Hearing (without monitoring program)
|
2.6%
4/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Eye disorders
Blurred vision
|
9.8%
15/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Constipation
|
56.9%
87/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
66.0%
101/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
78.4%
120/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
36.6%
56/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.6%
4/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Heartburn
|
18.3%
28/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
20.3%
31/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
9/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.0%
3/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Mucositis (clinical exam) Oral cavity
|
16.3%
25/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
9.8%
15/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) Oral cavity
|
23.5%
36/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
13.7%
21/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
102/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
62.1%
95/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Pain Abdomen NOS
|
22.2%
34/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
17.6%
27/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Gastrointestinal disorders
Vomiting
|
36.6%
56/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
38.6%
59/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Edema: limb
|
13.7%
21/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
16.3%
25/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Fatigue
|
83.0%
127/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
78.4%
120/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Fever
|
5.9%
9/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
14.4%
22/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Flu-like syndrome
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
General disorders
Pain Chest/thorax NOS
|
24.8%
38/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
28.1%
43/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Immune system disorders
Allergic reaction
|
8.5%
13/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
15.0%
23/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Lung
|
7.8%
12/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Upper airway NOS
|
9.8%
15/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
9.8%
15/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with normal ANC Urinary tract NOS
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Infections and infestations
Infection with unknown ANC Upper airway NOS
|
6.5%
10/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Investigations
Weight loss
|
22.9%
35/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
60.8%
93/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
50.3%
77/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.2%
14/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.8%
12/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Extremity-lower
|
9.2%
14/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.9%
9/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Whole body/generalized
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
6.5%
10/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Back
|
26.1%
40/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
24.8%
38/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Bone
|
17.6%
27/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
17.6%
27/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Chest wall
|
11.1%
17/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
13.1%
20/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Extremity-limb
|
22.2%
34/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
15.7%
24/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Joint
|
37.9%
58/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
43.8%
67/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Muscle
|
35.9%
55/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
49.0%
75/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain Neck
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain Tumor pain
|
8.5%
13/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
12.4%
19/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Dizziness
|
24.2%
37/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
19.0%
29/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Memory impairment
|
6.5%
10/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
2.6%
4/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Neuropathy-motor
|
9.8%
15/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.9%
9/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
71.9%
110/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
71.9%
110/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Pain Head/headache
|
32.0%
49/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
22.9%
35/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Nervous system disorders
Taste alteration
|
20.9%
32/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
17.0%
26/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Psychiatric disorders
Confusion
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
6.5%
10/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Psychiatric disorders
Insomnia
|
30.1%
46/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
34.6%
53/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Psychiatric disorders
Mood alteration Anxiety
|
17.6%
27/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
21.6%
33/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Psychiatric disorders
Mood alteration Depression
|
8.5%
13/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
13.7%
21/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
9/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
0.65%
1/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
69.9%
107/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
70.6%
108/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
68.0%
104/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
60.1%
92/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary Lung
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
5.9%
9/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary Nose
|
22.9%
35/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.8%
12/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
3.3%
5/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pain Throat/pharynx/larynx
|
7.8%
12/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.8%
12/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
19.0%
29/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
9.8%
15/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
79.1%
121/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
75.8%
116/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.4%
19/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Skin and subcutaneous tissue disorders
Hand-foot
|
7.2%
11/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
3.9%
6/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
12/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
9.8%
15/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.7%
47/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
23.5%
36/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.9%
6/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
6.5%
10/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Vascular disorders
Hypertension
|
50.3%
77/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
13.7%
21/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Vascular disorders
Hypotension
|
5.2%
8/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
4.6%
7/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
10.5%
16/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
9.8%
15/153 • from the start of treatment to time of 4 weeks after stopped the treatment.
|
Additional Information
Dr. Scott Laurie
Division of Medical Oncology, the Ottawa Hospital, Ottawa, Ontario, Canada
Phone: 1-613-737-7700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place