Clinical trial NCT02328105: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2014-12-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With a Response
timeFrame: Up to a planned 18 weeks
Secondary outcomes:
measure: Number of Subjects With Stable Disease or Response
timeFrame: 18 weeks
measure: Progression Free Survival
timeFrame: From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 3 years
measure: Overall Survival
timeFrame: From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years
measure: Duration of Response
timeFrame: From date of response to date of progression/death, or censored as described above; assessed for approximately 3 years.
measure: Duration of Disease Control
timeFrame: From date of treatment start to date of progression, or censored as described above; assessed for approximately 3 years
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathryn Mileham, M.D.
role: PRINCIPAL_INVESTIGATOR
References: