Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02590003

Recruitment Status : Terminated (Trial was stopped after non-response to treatment.)

First Posted : October 28, 2015

Results First Posted : February 28, 2018

Last Update Posted : February 28, 2018

Sponsor:

Information provided by (Responsible Party):

Yale University

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Carcinoma, Non-small Cell Lung
Interventions	Drug: Carboplatin Drug: Nab-paclitaxel
Enrollment	3

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Period Title: Overall Study
Started	1	2
Completed	0	0
Not Completed	1	2
Reason Not Completed
Death	1	2

Baseline Characteristics

Arm/Group Title		Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy	Total
Arm/Group Description		Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...	Total of all reporting groups
Arm/Group Description		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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel	Total of all reporting groups
Overall Number of Baseline Participants		1	2	3
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1 participants	2 participants	3 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	1 100.0%	2 100.0%	3 100.0%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1 participants	2 participants	3 participants
	Female	1 100.0%	1 50.0%	2 66.7%
	Male	0 0.0%	1 50.0%	1 33.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1 participants	2 participants	3 participants
	Hispanic or Latino	0 0.0%	1 50.0%	1 33.3%
	Not Hispanic or Latino	0 0.0%	1 50.0%	1 33.3%
	Unknown or Not Reported	1 100.0%	0 0.0%	1 33.3%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1 participants	2 participants	3 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	1 50.0%	1 33.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 100.0%	1 50.0%	2 66.7%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	1 participants	2 participants	3 participants
United States		1 100.0%	2 100.0%	3 100.0%

Outcome Measures

1.Primary Outcome


Title	Treatment Failure-free Survival
Description	[Not Specified]
Description	[Not Specified]
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description:	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description:	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Overall Number of Participants Analyzed	1	2
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%

2.Secondary Outcome


Title	Overall Response Rate
Description	[Not Specified]
Description	[Not Specified]
Time Frame	start of treatment to disease progression/recurrence, up to 12 months

Outcome Measure Data

Analysis Population Description

The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description:	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description:	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Overall Number of Participants Analyzed	1	2
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%

3.Secondary Outcome


Title	Progression-free Survival
Description	[Not Specified]
Description	[Not Specified]
Time Frame	start of treatment to disease progression, up to 12 months

Outcome Measure Data

Analysis Population Description

The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description:	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description:	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Overall Number of Participants Analyzed	1	2
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%

4.Secondary Outcome


Title	Overall Survival
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description:	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description:	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Overall Number of Participants Analyzed	1	2
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%

5.Secondary Outcome


Title	Grade 3-5 Adverse Events
Description	Adverse events were characterized using Common Terminology Criteria fo...
Description	Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame	Up to week 13

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description:	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description:	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Overall Number of Participants Analyzed	1	2
Measure Type: Count of Participants Unit of Measure: Participants
Overall	0 0.0%	2 100.0%
Grade 3	0 0.0%	2 100.0%
Grade 4	0 0.0%	0 0.0%
Grade 5	0 0.0%	0 0.0%

6.Secondary Outcome


Title	Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)
Description	The FACT-L is measure of symptoms associated with lung cancer. The hig...
Description	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.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description:	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description:	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Overall Number of Participants Analyzed	1	2
Mean (Standard Deviation) Unit of Measure: units on a scale
	89 ^[1] (NA)	44 (26.9)

[1]

Standard deviation is not calculated.

7.Secondary Outcome


Title	Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)
Description	The higher the score, the greater the symptoms. The FACT-L is measure ...
Description	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.
Time Frame	week 6

Outcome Measure Data

Analysis Population Description

Only 2 patients were assessed at this timepoint.


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description:	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description:	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Overall Number of Participants Analyzed	0	2
Mean (Standard Deviation) Unit of Measure: units on a scale
		60.5 (19.1)

8.Secondary Outcome


Title	Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)
Description	The FACT-L is measure of symptoms associated with lung cancer. The hig...
Description	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.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Platinum-based Doublet Chemotherapy	Single Agent Chemotherapy
Arm/Group Description:	Carboplatin AUC 5 30 minute infusio...	-Nab-paclitaxel 100mg/mg2 30 minute...
Arm/Group Description:	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	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Single Agent Chemotherapy		Platinum-based Doublet Chemotherapy
Arm/Group Description	-Nab-paclitaxel 100mg/mg2 30 minute...		Carboplatin AUC 5 30 minute infusio...
Arm/Group Description	-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle Nab-paclitaxel		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
All-Cause Mortality
	Single Agent Chemotherapy		Platinum-based Doublet Chemotherapy
	Affected / at Risk (%)		Affected / at Risk (%)
Total	2/2 (100.00%)		1/1 (100.00%)
Serious Adverse Events Serious Adverse Events
	Single Agent Chemotherapy		Platinum-based Doublet Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50.00%)		0/1 (0.00%)
Blood and lymphatic system disorders
Hyponatremia ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Thromboembolic event ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Pleural effusion ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Dyspnea ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Non-cardiac chest pain ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Skin and subcutaneous tissue disorders
Edema limbs ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Single Agent Chemotherapy		Platinum-based Doublet Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100.00%)		0/1 (0.00%)
Blood and lymphatic system disorders
Anemia ^†	2/2 (100.00%)	4	0/1 (0.00%)	0
Blood disorder ^†	1/2 (50.00%)	2	0/1 (0.00%)	0
Creatinine Increase ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Hyperkalemia ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Hypoalbuminemia ^†	2/2 (100.00%)	2	0/1 (0.00%)	0
Hypocalcemia ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Hyponatremia ^†	2/2 (100.00%)	6	0/1 (0.00%)	0
Lymphocyte count decreased ^†	2/2 (100.00%)	7	0/1 (0.00%)	0
White blood cell decreased ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Eye disorders
Eye Pain ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Gastrointestinal disorders
Constipation ^†	2/2 (100.00%)	3	0/1 (0.00%)	0
General disorders
Epistaxis ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Fatigue ^†	2/2 (100.00%)	2	0/1 (0.00%)	0
Insomnia ^†	2/2 (100.00%)	3	0/1 (0.00%)	0
Pain ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Infections and infestations
Mucositis oral ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Metabolism and nutrition disorders
Anorexia ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Hyperglycemia ^†	1/2 (50.00%)	2	0/1 (0.00%)	0
Musculoskeletal and connective tissue disorders
Bone pain ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Nervous system disorders
Confusion ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Peripheral sensory neuropathy ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough ^†	2/2 (100.00%)	2	0/1 (0.00%)	0
Dyspnea ^†	2/2 (100.00%)	3	0/1 (0.00%)	0
Non-cardiac chest pain ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Skin and subcutaneous tissue disorders
Edema Limbs ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Skin infection ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
Vascular disorders
Hypertension ^†	2/2 (100.00%)	3	0/1 (0.00%)	0
Hypotension ^†	1/2 (50.00%)	1	0/1 (0.00%)	0
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Rogerio C. Lilenbaum, MD, Professor of Medicine (Medical Oncology); Chief Medical Officer of Smilow
Organization:	Yale University
Phone:	(203) 200-5864
EMail:	rogerio.lilenbaum@yale.edu

Layout table for additonal information

Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT02590003
Other Study ID Numbers:	1403013529
First Submitted:	October 12, 2015
First Posted:	October 28, 2015
Results First Submitted:	November 3, 2017
Results First Posted:	February 28, 2018
Last Update Posted:	February 28, 2018

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