Non Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
LCCC 1210 - 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)
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).
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