Single Arm on the Tolerability of Weekly Nab-paclitaxel
Condition: Non Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nab-Paclitaxel
Intervention description: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Nab paclitaxel; Abraxane; First Line; Non small cell lung cancer; NSCLC; Phase II; Non-Randomized; Elderly; Lineberger; UNC; LCCC 1210

Summary:

      The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel for
      a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell
      lung cancer (NSCLC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent

          -  Male or female patient

          -  Greater than or equal to 70 years of age

          -  Diagnosis of NSCLC histologically or cytologically confirmed

          -  Internal Association for the Study of Lung Cancer Version 7 Stage IV disease or
             recurrence after prior surgery or radiotherapy

          -  Progression following one line of prior chemotherapy consisting of a platinum agent
             plus a standard cytotoxic partner agent other than a taxane, typically pemetrexed
             gemcitabine or vinorelbine

          -  A single agent non cytoxic regimen if the patient has a molecular change that the non
             cytotoxic regimen would be expected to be efficacious for epidermal growth factor
             receptor (EGFR) mutation for erlotinib and (EML4) anaplastic lymphoma kinase (ALk) or
             ROS1 for crizotinib

          -  Eastern Cooperative Oncology Group performance status 0 to 2

          -  Adequate organ and bone marrow function as defined by

          -  Absolute neutrophil count greater than or equal to 1500 cells/mm3

          -  Creatinine less than or equal to 1.5 mg dL

          -  Total bilirubin less than or equal to 1.5 mg dL

          -  Alkaline phosphatase less than or equal to 2.5 x upper limit of normal

          -  Alanine aminotransferase less than or equal to 2.5 x upper limit of normal

          -  Aspartate aminotransferase less than or equal to 2.5 upper limit of normal

          -  Recovered from all reversible toxicities related to their previous treatment to less
             than or equal to grade 1 or baseline

          -  Patients must have equal to grade 2 pre existing peripheral neuropathy

          -  Women of childbearing potential and sexually active men must agree to use effective
             contraception prior to study entry for the duration of study participation and for
             three months after completing treatment. Adequate contraception is defined as any
             medically recommended method as per standard of care

          -  Negative serum or urine bhCG pregnancy test at screening for patients of childbearing
             potential

          -  Patients with brain metastases may participate if they have undergone appropriate
             treatment for the lesions are at least two weeks post treatment without evidence for
             post treatment progression have no significant neurologic symptoms and no longer
             require steroids for the reason of brain metastases. Patients with symptoms suggestive
             of central nervous system (CNS) metastases should be evaluated with imaging prior to
             study participation

        Exclusion Criteria:

          -  Prior taxane therapy for any indication

          -  Less than 3 weeks elapsed since prior exposure to chemotherapy

          -  Pre existing neuropathy greater than grade 1

          -  Other active invasive malignancy requiring ongoing therapy or expected to require
             systemic therapy within two years localized squamous cell carcinoma of the skin basal
             cell carcinoma of the skin, carcinoma in situ of teh cervix or other malignancies
             requiring locally ablative therapy only will not result in exclusion

          -  Concomitant anticancer therapy immunotherapy or radiation therapy within prior 4 weeks

          -  Have received treatment within the last 30 days prior to study entry with any drug
             that has not receive regulatory approval for an indication at the time of study entry

          -  Uncontrolled intercurrent illness including but not limited to ongoing or active
             infection requiring IV antibiotics symptomatic congestive heart failure unstable
             angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that
             would limit compliance with study requirements

          -  Pregnant women are excluded due to the potential for teratogenic or abortifacient
             effects of nab paclitaxel because there is a potential risk for adverse events in
             nursing infants secondary to treatment of the mother with these agents, breastfeeding
             should be discontinued prior to participation of the mother on study

          -  Known hypersensitivity to protein bound paclitaxel

          -  Any other concurrent condition that in the investigators opinion would jeopardize
             compliance with the protocol