SHS_492248 WESH CUNC 14056

A Phase II, multicenter, single arm study of the tolerability of weekly nab-paclitaxel as second line treatment for elderly patients with advanced lung cancer

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)

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 EGFR mutation for erlotinib and EML4 ALk or ROS1 for crizotinib
Eastern Cooperative Oncology Group performance status 0 to 2
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 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
Phase II
NCT01702844
Cancer, All Other
Lung
Howard (Jack) West, M.D.
University of North Carolina
Andrew Smith
  • Swedish Medical Center