Trial Outcomes & Findings for Phase II Iressa & Carbo/Gem in NSCLC (NCT NCT00264498)
NCT ID: NCT00264498
Last Updated: 2009-08-03
Results Overview
Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Date of randomization to earliest date of objective disease progression
Results posted on
2009-08-03
Participant Flow
Patients were recruited at 2 Canadian cancer clinics between October 2004 and October 2007.
Following enrolment there was a 7 - 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment. Following objective disease progression on randomized treatment (Period 1), subjects were encouraged to crossover to the other treatment (Period 2).
Participant milestones
| Measure |
Active Comparator
Gemcitabine + Carboplatin
|
Experimental
Gefitinib
|
|---|---|---|
|
Randomized Treatment
STARTED
|
17
|
18
|
|
Randomized Treatment
COMPLETED
|
0
|
0
|
|
Randomized Treatment
NOT COMPLETED
|
17
|
18
|
|
Crossover Treatment
STARTED
|
6
|
9
|
|
Crossover Treatment
COMPLETED
|
0
|
0
|
|
Crossover Treatment
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Active Comparator
Gemcitabine + Carboplatin
|
Experimental
Gefitinib
|
|---|---|---|
|
Randomized Treatment
Death
|
0
|
3
|
|
Randomized Treatment
Withdrawal by Subject
|
0
|
1
|
|
Randomized Treatment
Objective disease Progression
|
13
|
14
|
|
Randomized Treatment
Physician Decision
|
1
|
0
|
|
Randomized Treatment
Incorrectly randomized
|
1
|
0
|
|
Randomized Treatment
Study Closure
|
1
|
0
|
|
Randomized Treatment
Protocol Violation
|
1
|
0
|
|
Crossover Treatment
Death
|
1
|
3
|
|
Crossover Treatment
Objective disease progression
|
4
|
5
|
|
Crossover Treatment
Study closure
|
0
|
1
|
|
Crossover Treatment
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Phase II Iressa & Carbo/Gem in NSCLC
Baseline characteristics by cohort
| Measure |
Active Comparator
n=17 Participants
Gemcitabine + Carboplatin
|
Experimental
n=18 Participants
Gefitinib
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
Age at screening
|
67.8 Years
STANDARD_DEVIATION 6.01 • n=5 Participants
|
66.2 Years
STANDARD_DEVIATION 8.24 • n=7 Participants
|
67.0 Years
STANDARD_DEVIATION 7.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8.0 Participants
n=5 Participants
|
6.0 Participants
n=7 Participants
|
14.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9.0 Participants
n=5 Participants
|
12.0 Participants
n=7 Participants
|
21.0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
16.0 Participants
n=5 Participants
|
12.0 Participants
n=7 Participants
|
28.0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1.0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1.0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
0 Participants
n=5 Participants
|
4.0 Participants
n=7 Participants
|
4.0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0.0 Participants
n=5 Participants
|
2.0 Participants
n=7 Participants
|
2.0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date of randomization to earliest date of objective disease progressionInterval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression
Outcome measures
| Measure |
Active Comparator
n=17 Participants
Gemcitabine + Carboplatin
|
Experimental
n=18 Participants
Gefitinib
|
|---|---|---|
|
Progression Free Survival (PFS)
|
131.0 Days
95% Confidence Interval 66.0000 • Interval 66.0 to 190.0
|
42.0 Days
95% Confidence Interval 35.0000 • Interval 35.0 to 90.0
|
Adverse Events
Active Comparator
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Experimental
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Comparator
Gemcitabine + Carboplatin
|
Experimental
Gefitinib
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.3%
1/23
|
0.00%
0/26
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/23
|
3.8%
1/26
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23
|
0.00%
0/26
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/23
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.3%
1/23
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.3%
1/23
|
0.00%
0/26
|
Other adverse events
| Measure |
Active Comparator
Gemcitabine + Carboplatin
|
Experimental
Gefitinib
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
30.4%
7/23
|
0.00%
0/26
|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
2/23
|
0.00%
0/26
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.7%
2/23
|
0.00%
0/26
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
2/23
|
53.8%
14/26
|
|
Gastrointestinal disorders
Nausea
|
47.8%
11/23
|
30.8%
8/26
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23
|
26.9%
7/26
|
|
Gastrointestinal disorders
Constipation
|
52.2%
12/23
|
11.5%
3/26
|
|
Gastrointestinal disorders
Stomatitis
|
8.7%
2/23
|
11.5%
3/26
|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
2/23
|
7.7%
2/26
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23
|
7.7%
2/26
|
|
Gastrointestinal disorders
Abdominal distension
|
8.7%
2/23
|
0.00%
0/26
|
|
Gastrointestinal disorders
Toothache
|
8.7%
2/23
|
0.00%
0/26
|
|
Gastrointestinal disorders
Fatigue
|
43.5%
10/23
|
23.1%
6/26
|
|
Gastrointestinal disorders
Asthenia
|
21.7%
5/23
|
23.1%
6/26
|
|
Gastrointestinal disorders
Oedema peripheral
|
13.0%
3/23
|
11.5%
3/26
|
|
Gastrointestinal disorders
Pyrexia
|
4.3%
1/23
|
11.5%
3/26
|
|
Gastrointestinal disorders
Chest pain
|
0.00%
0/23
|
11.5%
3/26
|
|
Gastrointestinal disorders
Catheter site pain
|
13.0%
3/23
|
3.8%
1/26
|
|
Gastrointestinal disorders
Pain
|
13.0%
3/23
|
0.00%
0/26
|
|
Gastrointestinal disorders
Pitting oedema
|
8.7%
2/23
|
0.00%
0/26
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23
|
7.7%
2/26
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
2/23
|
3.8%
1/26
|
|
Infections and infestations
Weight decreased
|
8.7%
2/23
|
7.7%
2/26
|
|
Metabolism and nutrition disorders
Anorexia
|
8.7%
2/23
|
15.4%
4/26
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/23
|
15.4%
4/26
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
17.4%
4/23
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/23
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.7%
2/23
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.7%
2/23
|
3.8%
1/26
|
|
Nervous system disorders
Headache
|
21.7%
5/23
|
15.4%
4/26
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/23
|
15.4%
4/26
|
|
Nervous system disorders
Dizziness
|
17.4%
4/23
|
7.7%
2/26
|
|
Nervous system disorders
Somnolence
|
8.7%
2/23
|
0.00%
0/26
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23
|
11.5%
3/26
|
|
Psychiatric disorders
Anxiety
|
8.7%
2/23
|
7.7%
2/26
|
|
Psychiatric disorders
Confusional state
|
8.7%
2/23
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
43.5%
10/23
|
34.6%
9/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
4/23
|
23.1%
6/26
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.7%
2/23
|
11.5%
3/26
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
13.0%
3/23
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.7%
2/23
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/23
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.1%
6/23
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.0%
3/23
|
3.8%
1/26
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.0%
3/23
|
23.1%
6/26
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
1/23
|
19.2%
5/26
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23
|
15.4%
4/26
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.7%
2/23
|
7.7%
2/26
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/23
|
7.7%
2/26
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
8.7%
2/23
|
3.8%
1/26
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
2/23
|
0.00%
0/26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60