Trial Outcomes & Findings for Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer (NCT NCT00469898)
NCT ID: NCT00469898
Last Updated: 2012-07-27
Results Overview
Patient response to treatment: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
COMPLETED
PHASE2
50 participants
1.66 months (average duration, on treatment date to best response date)
2012-07-27
Participant Flow
Recruitment Period = 2/18/2004 through 1/23/2007
A total of 54 people signed consent to take part in the study. Of those, 3 were found to be ineligible and 1 withdrew before beginning the study.
Participant milestones
| Measure |
Therapeutic Intervention
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Therapeutic Intervention
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
4
|
|
Overall Study
Disease progression
|
9
|
|
Overall Study
Decreased performance status
|
1
|
Baseline Characteristics
Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Therapeutic Intervention
n=50 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age Continuous
|
59.5 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.66 months (average duration, on treatment date to best response date)Patient response to treatment: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
Outcome measures
| Measure |
Therapeutic Intervention
n=50 Participants
|
|---|---|
|
Patient Response
Complete Response
|
2 participants
|
|
Patient Response
Not Assessed
|
1 participants
|
|
Patient Response
Not Evaluable
|
2 participants
|
|
Patient Response
Partial Response
|
27 participants
|
|
Patient Response
Progressive Disease
|
12 participants
|
|
Patient Response
Stable Disease
|
1 participants
|
|
Patient Response
Unknown
|
5 participants
|
SECONDARY outcome
Timeframe: date off treatment or progression of disease, up to 18 weeksNumber of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event
Outcome measures
| Measure |
Therapeutic Intervention
n=50 Participants
|
|---|---|
|
Number of Patients With Adverse Events
Grade 1
|
13 participants
|
|
Number of Patients With Adverse Events
Grade 2
|
26 participants
|
|
Number of Patients With Adverse Events
Grade 3
|
29 participants
|
|
Number of Patients With Adverse Events
Grade 4
|
10 participants
|
|
Number of Patients With Adverse Events
Grade 5
|
4 participants
|
SECONDARY outcome
Timeframe: 9.9 months (on study date to progression)Population: Patients who has progression
Time to progression in months
Outcome measures
| Measure |
Therapeutic Intervention
n=40 Non censoring patients
|
|---|---|
|
Time to Progression
|
5 Months
Interval 1.0 to 17.0
|
SECONDARY outcome
Timeframe: On study date to deathOutcome measures
| Measure |
Therapeutic Intervention
n=50 Participants
|
|---|---|
|
Overall Survival
|
9 Months
Interval 0.0 to 42.0
|
Adverse Events
Therapeutic Intervention
Serious adverse events
| Measure |
Therapeutic Intervention
n=50 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
2/50 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis pain
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Asystole/Possible PE
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back and shoulder pain
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Cardiac infarction
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Death due to disease progression
|
4.0%
2/50 • Number of events 2
|
|
General disorders
Death, unknown cause
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Decrease in platelet count
|
10.0%
5/50 • Number of events 5
|
|
Investigations
Decreased neutrophil count
|
12.0%
6/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
5/50 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
6.0%
3/50 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
4/50 • Number of events 4
|
|
Nervous system disorders
Fainting
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Fatigue
|
8.0%
4/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.0%
3/50 • Number of events 3
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Decreased hemoglobin
|
8.0%
4/50 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Left proximal humerus fracture
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
16.0%
8/50 • Number of events 8
|
|
Gastrointestinal disorders
Peri-rectal abscess
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Post-obstructive pneumonitis
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Tremor
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
5/50 • Number of events 5
|
|
Investigations
Weight loss
|
4.0%
2/50 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place