Trial Outcomes & Findings for Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer (NCT NCT02590003)
NCT ID: NCT02590003
Last Updated: 2018-02-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
90 days
Results posted on
2018-02-28
Participant Flow
Participant milestones
| Measure |
Platinum-based Doublet Chemotherapy
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Platinum-based Doublet Chemotherapy
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
Baseline Characteristics
Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Platinum-based Doublet Chemotherapy
n=1 Participants
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
n=2 Participants
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Platinum-based Doublet Chemotherapy
n=1 Participants
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
n=2 Participants
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Treatment Failure-free Survival
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: start of treatment to disease progression/recurrence, up to 12 monthsPopulation: The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.
Outcome measures
| Measure |
Platinum-based Doublet Chemotherapy
n=1 Participants
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
n=2 Participants
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Overall Response Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: start of treatment to disease progression, up to 12 monthsPopulation: The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.
Outcome measures
| Measure |
Platinum-based Doublet Chemotherapy
n=1 Participants
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
n=2 Participants
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Progression-free Survival
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.
Outcome measures
| Measure |
Platinum-based Doublet Chemotherapy
n=1 Participants
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
n=2 Participants
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Overall Survival
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to week 13Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)
Outcome measures
| Measure |
Platinum-based Doublet Chemotherapy
n=1 Participants
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
n=2 Participants
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Grade 3-5 Adverse Events
Overall
|
0 Participants
|
2 Participants
|
|
Grade 3-5 Adverse Events
Grade 3
|
0 Participants
|
2 Participants
|
|
Grade 3-5 Adverse Events
Grade 4
|
0 Participants
|
0 Participants
|
|
Grade 3-5 Adverse Events
Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baselineThe FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained.
Outcome measures
| Measure |
Platinum-based Doublet Chemotherapy
n=1 Participants
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
n=2 Participants
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)
|
89 units on a scale
Standard Deviation NA
Standard deviation is not calculated.
|
44 units on a scale
Standard Deviation 26.9
|
SECONDARY outcome
Timeframe: week 6Population: Only 2 patients were assessed at this timepoint.
The higher the score, the greater the symptoms. The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained. Symptoms were measured following 2 21-day cycles of chemotherapy.
Outcome measures
| Measure |
Platinum-based Doublet Chemotherapy
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
Single Agent Chemotherapy
n=2 Participants
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
|---|---|---|
|
Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)
|
—
|
60.5 units on a scale
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: week 12Population: The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment, these data were not collected at week 12
The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. Symptoms were measured following 4 21-day cycles of chemotherapy.
Outcome measures
Outcome data not reported
Adverse Events
Single Agent Chemotherapy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Platinum-based Doublet Chemotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single Agent Chemotherapy
n=2 participants at risk
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
Platinum-based Doublet Chemotherapy
n=1 participants at risk
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Hyponatremia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Edema limbs
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
Other adverse events
| Measure |
Single Agent Chemotherapy
n=2 participants at risk
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Nab-paclitaxel
|
Platinum-based Doublet Chemotherapy
n=1 participants at risk
* Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Carboplatin
Nab-paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
2/2 • Number of events 4
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Blood disorder
|
50.0%
1/2 • Number of events 2
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
Confusion
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Constipation
|
100.0%
2/2 • Number of events 3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
2/2 • Number of events 2
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Creatinine Increase
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
2/2 • Number of events 3
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Edema Limbs
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Epistaxis
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Eye disorders
Eye Pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 2
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
100.0%
2/2 • Number of events 3
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
100.0%
2/2 • Number of events 2
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Hyponatremia
|
100.0%
2/2 • Number of events 6
|
0.00%
0/1
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Insomnia
|
100.0%
2/2 • Number of events 3
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
2/2 • Number of events 7
|
0.00%
0/1
|
|
Infections and infestations
Mucositis oral
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
Additional Information
Rogerio C. Lilenbaum, MD, Professor of Medicine (Medical Oncology); Chief Medical Officer of Smilow
Yale University
Phone: (203) 200-5864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place