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
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Carboplatin Drug: Abraxane||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LCI-LUN-ABR-001: A Pilot Study of Carboplatin With Nab-Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer of Squamous Histology|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||June 15, 2017|
|Actual Study Completion Date :||November 26, 2019|
Experimental: Carboplatin + Abraxane
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 Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
Dosing: AUC = 6; on Day 1
100 mg/m^2; Days 1, 8, 15
Other Name: nab-paclitaxel
- Number of Participants With a Response [ Time Frame: Up to a planned 18 weeks ]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.
- Number of Subjects With Stable Disease or Response [ Time Frame: 18 weeks ]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).
- Progression Free Survival [ Time Frame: From date of treatment start to date of progression/death, or censored as described above. ]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.
- Overall Survival [ Time Frame: From date of treatment start to date of death, or censored as described above. ]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.
- Duration of Response [ Time Frame: From date of response to date of progression/death, or censored as described above. ]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.
- Duration of Disease Control [ Time Frame: From date of treatment start to date of progression, or censored as described above. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328105
|United States, North Carolina|
|Levine Cancer Institute|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Kathryn Mileham, M.D.||Atrium Health|