Back to resultsLCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Abraxane
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Levine Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Carboplatin + Abraxane
Arm 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
Outcomes
Primary Outcome Measures
Number of Participants With a Response
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.
Secondary Outcome Measures
Number of Subjects With Stable Disease or Response
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
PFS is defined as time from enrollment to time of progression or death. Disease progression (PD) may be determined objectively per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of longest diameters of target lesions, a measurable increase in non-target lesion, or appearance of new lesions) or subjectively as determined by investigator (with evidence documented in the medical records). If the subject died without documented PD, date of progression will be date of death. For surviving subjects who did not have documented PD, PFS was censored at last radiologic assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS was censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experienced a PFS event following an interval equal to two or more scheduled radiologic assessments were censored at last assessment prior to first missed assessment.
Overall Survival
OS is defined as the duration of time from enrollment to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.
Duration of Response
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
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.
Full Information
NCT ID
NCT02328105
First Posted
December 17, 2014
Last Updated
August 5, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
Celgene
1. Study Identification
Unique Protocol Identification Number
NCT02328105
Brief Title
LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
December 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carboplatin + Abraxane
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Dosing: AUC = 6; on Day 1
Intervention Type
Drug
Intervention Name(s)
Abraxane
Other Intervention Name(s)
nab-paclitaxel
Intervention Description
100 mg/m^2; Days 1, 8, 15
Primary Outcome Measure Information:
Title
Number of Participants With a Response
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
Secondary Outcome Measure Information:
Title
Number of Subjects With Stable Disease or Response
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
Title
Progression Free Survival
Description
PFS is defined as time from enrollment to time of progression or death. Disease progression (PD) may be determined objectively per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of longest diameters of target lesions, a measurable increase in non-target lesion, or appearance of new lesions) or subjectively as determined by investigator (with evidence documented in the medical records). If the subject died without documented PD, date of progression will be date of death. For surviving subjects who did not have documented PD, PFS was censored at last radiologic assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS was censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experienced a PFS event following an interval equal to two or more scheduled radiologic assessments were censored at last assessment prior to first missed assessment.
Time Frame
From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 3 years
Title
Overall Survival
Description
OS is defined as the duration of time from enrollment to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were 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; assessed for approximately 3 years
Title
Duration of Response
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; assessed for approximately 3 years.
Title
Duration of Disease Control
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; assessed for approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Mileham, M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer
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