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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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Platinum-based Doublet Chemotherapy Single Agent Chemotherapy
Hide 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
Arm/Group Title Platinum-based Doublet Chemotherapy Single Agent Chemotherapy Total
Hide 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
Hide 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
1
 100.0%
2
 100.0%
3
 100.0%
1.Primary Outcome
Title Treatment Failure-free Survival
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Platinum-based Doublet Chemotherapy Single Agent Chemotherapy
Hide 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
Hide Description [Not Specified]
Time Frame start of treatment to disease progression/recurrence, up to 12 months
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame start of treatment to disease progression, up to 12 months
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description [Not Specified]
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame Up to week 13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Platinum-based Doublet Chemotherapy Single Agent Chemotherapy
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Platinum-based Doublet Chemotherapy Single Agent Chemotherapy
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 2 patients were assessed at this timepoint.
Arm/Group Title Platinum-based Doublet Chemotherapy Single Agent Chemotherapy
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Agent Chemotherapy Platinum-based Doublet Chemotherapy
Hide 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%)    
Hide 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
Hide 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
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