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LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328105
Recruitment Status : Completed
First Posted : December 31, 2014
Results First Posted : July 11, 2018
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Kathryn Mileham, Atrium Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Carboplatin
Drug: Abraxane
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carboplatin + Abraxane
Hide Arm/Group Description Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
Period Title: Overall Study
Started 11
Completed 0
Not Completed 11
Reason Not Completed
Death             6
Withdrawal by Subject             1
Still On Study in Follow-Up             4
Arm/Group Title Carboplatin + Abraxane
Hide Arm/Group Description Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  54.5%
>=65 years
5
  45.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
66.09  (8.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
2
  18.2%
Male
9
  81.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
1
   9.1%
Not Hispanic or Latino
9
  81.8%
Unknown or Not Reported
1
   9.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  18.2%
White
9
  81.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Number of Participants With a Response
Hide Description The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by >= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.
Time Frame Up to a planned 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population (or evaluable population) is defined as all subjects who have measurable disease present at baseline, have received at least one dose of study therapy, and have had their disease re-evaluated (either clinically or radiographically)
Arm/Group Title Carboplatin + Abraxane
Hide Arm/Group Description:
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
  36.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carboplatin + Abraxane
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Assuming the true overall response rate is 0.20 under the null hypothesis, then this design will provide 81% power to detect a difference of 0.15 under the alternative hypothesis, assuming a one-sided alpha = 0.09 significance level. A three stage design with n=15, 30 and 45 subjects was determined with the following rejection regions: For n = 15, the rejection region in number of responses (CR or PR) is 0 - 2, for n = 30 it is 3 - 6, and for n = 45 it is 7 - 12.
Statistical Test of Hypothesis P-Value 0.161
Comments This p-value is only based on partial enrollment of stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Response Rate
Estimated Value 0.364
Confidence Interval (2-Sided) 95%
0.109 to 0.692
Estimation Comments Confidence interval estimated using the Clopper Pearson method.
2.Secondary Outcome
Title Number of Subjects With Stable Disease or Response
Hide Description Disease control is calculated for each subject indicating whether or not they achieved an overall response of stable disease or better by RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions, a PR is indicated by >= 30% decrease in sum of longest diameter of target lesions with baseline as reference, and SD is neither sufficient shrinkage to qualify for PR nor sufficient growth, >=20%, to indicate progression).
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population (or evaluable population) is defined as all subjects who have measurable disease present at baseline, have received at least one dose of study therapy, and have had their disease re-evaluated (either clinically or radiographically).
Arm/Group Title Carboplatin + Abraxane
Hide Arm/Group Description:
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
9
  81.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carboplatin + Abraxane
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation only.
Method of Estimation Estimation Parameter Disease Control Rate
Estimated Value 0.818
Confidence Interval (2-Sided) 95%
0.482 to 0.977
Estimation Comments Confidence interval estimated using the Clopper Pearson method.
3.Secondary Outcome
Title Progression Free Survival
Hide Description PFS is defined as the duration of time from treatment start date to time of progression or death. Disease progression may be determined objectively as per RECIST 1.1 or subjectively as determined by the investigator. Evidence for subjective progressions must be documented in the eMR. For objective disease progression, date of PD is date of the radiologic assessment that identified RECIST-defined progressive disease. For subjective disease progression, date of PD is the date that the clinician makes the determination of disease progression. If the subject died without documented disease progression, date of progression will be date of death. For surviving subjects who do not have objectively documented disease progression, PFS will be censored at the date of last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented disease progression, PFS will be censored at date of last radiologic assessment prior to commencement of subsequent therapy.
Time Frame From date of treatment start to date of progression/death, or censored as described above.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival
Hide Description OS is defined as the duration of time from treatment start date to the date of death from any cause. Subjects who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive.
Time Frame From date of treatment start to date of death, or censored as described above.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Duration of Response
Hide Description For subjects who achieve a CR or PR, response duration will be measured from the first day of the response until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.
Time Frame From date of response to date of progression/death, or censored as described above.
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Duration of Disease Control
Hide Description For subjects who achieve SD or better, duration of disease control will be measured from the treatment start date until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.
Time Frame From date of treatment start to date of progression, or censored as described above.
Outcome Measure Data Not Reported
Time Frame Baseline, during treatment (up to a planned 18 weeks), and 30 days after treatment discontinuation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carboplatin + Abraxane
Hide Arm/Group Description Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
All-Cause Mortality
Carboplatin + Abraxane
Affected / at Risk (%)
Total   6/11 (54.55%)    
Hide Serious Adverse Events
Carboplatin + Abraxane
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
Infections and infestations   
Sepsis  1  1/11 (9.09%)  1
Lung infection  1  1/11 (9.09%)  1
Investigations   
Blood bilirubin increased  1  1/11 (9.09%)  1
Lymphocyte count decreased  1  1/11 (9.09%)  1
Neutrophil count decreased  1  1/11 (9.09%)  1
Platelet count decreased  1  1/11 (9.09%)  1
White blood cell decreased  1  1/11 (9.09%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/11 (9.09%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carboplatin + Abraxane
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  10/11 (90.91%) 
Thrombotic thrombocytopenic purpura  1  1/11 (9.09%) 
Cardiac disorders   
Sinus tachycardia  1  2/11 (18.18%) 
Eye disorders   
Conjunctivitis  1  1/11 (9.09%) 
Gastrointestinal disorders   
Diarrhea  1  4/11 (36.36%) 
Mucositis oral  1  4/11 (36.36%) 
Nausea  1  4/11 (36.36%) 
Vomiting  1  4/11 (36.36%) 
Constipation  1  2/11 (18.18%) 
Abdominal pain  1  1/11 (9.09%) 
Dysphagia  1  1/11 (9.09%) 
Gastrointestinal disorders - Other  1 [1]  1/11 (9.09%) 
Oral hemorrhage  1  1/11 (9.09%) 
Stomach pain  1  1/11 (9.09%) 
Toothache  1  1/11 (9.09%) 
Gastroesophageal reflux disease  1  1/11 (9.09%) 
General disorders   
Fatigue  1  9/11 (81.82%) 
Edema limbs  1  4/11 (36.36%) 
Chills  1  2/11 (18.18%) 
Localized edema  1  2/11 (18.18%) 
Fever  1  1/11 (9.09%) 
Urinary frequency  1  1/11 (9.09%) 
Urinary incontinence  1  1/11 (9.09%) 
Infusion related reaction  1  1/11 (9.09%) 
Neck edema  1  1/11 (9.09%) 
Non-cardiac chest pain  1  1/11 (9.09%) 
Cystitis noninfective  1  1/11 (9.09%) 
Infections and infestations   
Skin infection  1  2/11 (18.18%) 
Urinary tract infection  1  2/11 (18.18%) 
Lung infection  1  2/11 (18.18%) 
Gum infection  1  1/11 (9.09%) 
Sinusitis  1  1/11 (9.09%) 
Upper respiratory infection  1  1/11 (9.09%) 
Mucosal infection  1  1/11 (9.09%) 
Injury, poisoning and procedural complications   
Bruising  1  3/11 (27.27%) 
Investigations   
Platelet count decreased  1  8/11 (72.73%) 
Neutrophil count decreased  1  6/11 (54.55%) 
Alkaline phosphatase increased  1  3/11 (27.27%) 
Weight loss  1  3/11 (27.27%) 
Lymphocyte count decreased  1  1/11 (9.09%) 
White blood cell decreased  1  2/11 (18.18%) 
Creatinine increased  1  1/11 (9.09%) 
INR increased  1  1/11 (9.09%) 
Metabolism and nutrition disorders   
Hypomagnesemia  1  6/11 (54.55%) 
Hyponatremia  1  5/11 (45.45%) 
Hypoalbuminemia  1  4/11 (36.36%) 
Hypocalcemia  1  4/11 (36.36%) 
Hypokalemia  1  3/11 (27.27%) 
Anorexia  1  2/11 (18.18%) 
Hypophosphatemia  1  2/11 (18.18%) 
Hypercalcemia  1  1/11 (9.09%) 
Hyperglycemia  1  1/11 (9.09%) 
Dehydration  1  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/11 (27.27%) 
Pain in extremity  1  2/11 (18.18%) 
Chest wall pain  1  1/11 (9.09%) 
Myalgia  1  1/11 (9.09%) 
Generalized muscle weakness  1  1/11 (9.09%) 
Nervous system disorders   
Peripheral sensory neuropathy  1  7/11 (63.64%) 
Dizziness  1  3/11 (27.27%) 
Dysgeusia  1  2/11 (18.18%) 
Headache  1  1/11 (9.09%) 
Neuralgia  1  1/11 (9.09%) 
Syncope  1  1/11 (9.09%) 
Psychiatric disorders   
Confusion  1  1/11 (9.09%) 
Renal and urinary disorders   
Urinary tract obstruction  1  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/11 (27.27%) 
Dyspnea  1  3/11 (27.27%) 
Epistaxis  1  3/11 (27.27%) 
Productive cough  1  2/11 (18.18%) 
Allergic rhinitis  1  1/11 (9.09%) 
Bronchial obstruction  1  1/11 (9.09%) 
Sore throat  1  1/11 (9.09%) 
Wheezing  1  1/11 (9.09%) 
Bronchial stricture  1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  4/11 (36.36%) 
Rash maculo-papular  1  4/11 (36.36%) 
Dry skin  1  2/11 (18.18%) 
Pruritus  1  2/11 (18.18%) 
Photosensitivity  1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders - Other  1 [2]  1/11 (9.09%) 
Skin ulceration  1  1/11 (9.09%) 
Vascular disorders   
Hypotension  1  3/11 (27.27%) 
Hot flashes  1  1/11 (9.09%) 
Hypertension  1  1/11 (9.09%) 
Thromboembolic event  1  1/11 (9.09%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Oral candidiasis
[2]
Contact dermatitis
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: Chair of Biostatistics Department
Organization: Levine Cancer Institute
Phone: 9804422371
EMail: james.symanowski@atriumhealth.org
Layout table for additonal information
Responsible Party: Kathryn Mileham, Atrium Health
ClinicalTrials.gov Identifier: NCT02328105    
Other Study ID Numbers: LCI-LUN-ABR-001
00010224
First Submitted: December 17, 2014
First Posted: December 31, 2014
Results First Submitted: June 14, 2018
Results First Posted: July 11, 2018
Last Update Posted: January 2, 2020