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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

Tracking Information
First Submitted Date  ICMJE December 17, 2014
First Posted Date  ICMJE December 31, 2014
Results First Submitted Date  ICMJE June 14, 2018
Results First Posted Date  ICMJE July 11, 2018
Last Update Posted Date January 2, 2020
Study Start Date  ICMJE December 2014
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 26, 2014)
Response Rate (RR) [ Time Frame: 18 weeks ]
Response will be assessed by RECIST
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer
Official Title  ICMJE LCI-LUN-ABR-001: A Pilot Study of Carboplatin With Nab-Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer of Squamous Histology
Brief Summary ABRAXANE, based on results from prior studies, is a promising drug in squamous cell carcinoma of the lung. This study will help to explore the combination of ABRAXANE and carboplatin more thoroughly in the subgroup of patients who had the best response in prior studies as well as determine whether there are any biomarkers which can predict for response.
Detailed Description This is a single arm phase II study for subjects receiving first line therapy for metastatic squamous cell lung cancer. Following informed consent and eligibility check, all subjects will receive therapy with carboplatin and ABRAXANE on an outpatient basis. A total of 50 subjects will be enrolled over an enrollment period of about 24 months. Interim analyses will be conducted after the enrollment of subject 15, subject 30, and subject 45. Tissue biomarkers will be analyzed at baseline; and blood biomarkers will be analyzed at baseline, pre-dose on cycles 3 and 5, and then within 30 days of last dose of study treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Carboplatin
    Dosing: AUC = 6; on Day 1
  • Drug: Abraxane
    100 mg/m^2; Days 1, 8, 15
    Other Name: nab-paclitaxel
Study Arms  ICMJE 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
Interventions:
  • Drug: Carboplatin
  • Drug: Abraxane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2017)
11
Original Estimated Enrollment  ICMJE
 (submitted: December 26, 2014)
50
Actual Study Completion Date  ICMJE November 26, 2019
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed stage IV non-small cell lung cancer with predominantly squamous histology
  • No prior systemic treatment for metastatic disease. Patients who have received prior adjuvant chemotherapy for early-stage lung cancer are eligible if at least 12 months have elapsed between the date of final chemotherapy administration and the date of consent
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with CT scan, MRI, or calipers by clinical exam
  • Biopsy accessible disease
  • Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Definitive radiation therapy must have been completed >4 weeks prior to the date the informed consent is signed
  • Age >18 years
  • ECOG performance status less than or equal to 1
  • If patient has brain metastasis, the disease must be stable (treated and/or asymptomatic) for at least 4 weeks prior to first dose of study treatment
  • Bilirubin < 1.5 mg/dL
  • Adequate liver function: AST and ALT <= 2.5x upper limit of normal, alkaline phosphatase <= 2.5x upper limit of normal, unless bone metastasis is present (< 5x upper limit of normal) in the absence of liver metastasis
  • Adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 9.0g/dL and ANC > 1,500 cells/mm3
  • Adequate renal function with creatinine <1.5 mg/dL is recommended
  • Females of childbearing potential and sexually active males must use an effective contraception method during treatment and for six months after completing treatment
  • Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential
  • Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE version 4.0)
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Received prior systemic therapy for metastatic disease
  • Received limited field radiation for palliation <= 2 weeks prior to starting study treatment and/or from whom >= 30% bone marrow was irradiated
  • Receiving any other investigational agents
  • Known hypersensitivity to either carboplatin or ABRAXANE
  • Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breast feeding
  • Other active malignancies
  • Neuropathy greater than or equal to grade 2
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02328105
Other Study ID Numbers  ICMJE LCI-LUN-ABR-001
00010224
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kathryn Mileham, Atrium Health
Study Sponsor  ICMJE Kathryn Mileham
Collaborators  ICMJE Celgene
Investigators  ICMJE
Principal Investigator: Kathryn Mileham, M.D. Atrium Health
PRS Account Atrium Health
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP