Single Arm on the Tolerability of Weekly Nab-paclitaxel
Single Arm on the Tolerability of Weekly Nab-paclitaxel
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)
This will be a non-randomized phase II study evaluating the safety and efficacy of weekly
 nab-paclitaxel for second-line treatment in 42 elderly patients, who are 70 years of age or
 greater with non-small cell lung cancer (NSLC). Patients will be required to have progressed
 on a single prior regimen. Nab-paclitaxel 100mg/m2 will be administered intravenously, weekly
 for 3 weeks of every 4-week cycle. After every two cycles of therapy, imaging will be
 performed to assess for response. Patients will be eligible to continue receiving therapy
 until the time of disease progression.

 Primary Objectives To evaluate the tolerability of weekly nab-paclitaxel in older adults with
 advanced lung cancer who have progressed on at least 1 prior regimen after 6 cycles or 3
 weeks after discontinuation of treatment, for those who come off treatment earlier.

 Secondary Objectives To estimate overall survival To estimate progression-free survival To
 estimate the response rate

 Correlative Objectives To explore baseline components of the Geriatric Assessment (GA) as
 predictors of chemotherapy tolerance and overall survival To explore the use of p16
 measurements in the elderly as predictors of chemotherapy tolerance and overall survival To
 explore the impact of weekly nab-paclitaxel treatment on quality of life, as measured by Lung
 Cancer Symptom Scale (LCSS) and Functional Assessment of Cancer Therapy-Lung (FACT-L).
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