LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Carboplatin; Abraxane
Intervention description: Dosing: AUC = 6; on Day 1; 100 mg/m^2; Days 1, 8, 15
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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