Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer
Condition: Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Laboratory Biomarker Analysis; Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Intervention description: Correlative studies; Given IV
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle
      formulation) in patients with lung cancer. Abraxane is a chemotherapy approved to treat
      patients with breast cancer. Doctors want to know if Abraxane is safe and effective in
      treating patients with lung cancer that has spread to other places in the body and usually
      cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor
      (EGFR) mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in
             tumor deoxyribonucleic acid (DNA) or complete/partial response to first line EGFR
             tyrosine kinase inhibitors with > or = to 6 months duration of response in patients
             who do not have a confirmed EGFR mutation

          -  At least one site of measurable disease as determined by the Investigator, using
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

          -  Progressive disease with radiographic evidence of disease progression per investigator
             assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic
             setting; patients may continue EGFR inhibitor therapy throughout the screening period
             until the day prior to nab-paclitaxel treatment initiation

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at the time of
             informed consent

          -  Platelet count >= 100,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Hemoglobin >= 9 g/dL

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 2.5 times
             upper limit of normal

          -  Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is
             present in the absence of liver metastasis

          -  Bilirubin =< 1.5 mg/dL

          -  Creatinine =< 1.5 mg/dL

          -  Women of child-bearing potential (WOCP) and sexually active men must agree to use
             adequate contraception (hormonal or barrier method of birth control or abstinence)
             prior to study entry, during treatment and for three months after completing treatment

          -  Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at
             screening for patients of childbearing potential

          -  Life expectancy of > 12 weeks

          -  Signed and dated informed consent document indicating that the patient has been
             informed of all the pertinent aspects of the trial prior to enrollment

        Exclusion Criteria:

          -  Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior
             adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6
             months elapsed prior to documented metastatic recurrence

          -  A single dose of a platinum doublet discontinued due to intolerability without
             evidence of disease progression is permitted

          -  Patient is < 5 years free of another primary malignancy, except: a) if the other
             malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other
             primary malignancy is not considered clinically significant and is requiring no active
             intervention

          -  Progressive or symptomatic central nervous system (CNS) metastases; patients with
             known brain metastasis must have stable disease following treatment with surgery,
             radiation or both; in addition, they must be off corticosteroids

          -  Radiotherapy within 7 days of study treatment

          -  Peripheral neuropathy grade 2 or greater

          -  Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA)
             criteria, or myocardial infarction within 6 months

          -  Any serious or uncontrolled concomitant disorder that, in the opinion of the
             investigator, would compromise the patient's ability to complete the study

          -  Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or
             cirrhosis

          -  Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study
             treatment; placement of vascular access device and biopsies allowed and is not
             considered major or minor surgery

          -  Patient with any significant history of non-compliance to medical regimens or with
             inability to grant reliable informed consent

          -  Pregnant or breast feeding females