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
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 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 LCSS and FACT-L.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of subjects with adverse events
Tolerability of weekly nab-paclitaxel, as measured by occurrence of Grade 3 or worse toxicity after 6 cycles or 3 weeks after discontinuation of treatment, for those who came off treatment earlier as measured by CTCAE, version 4
6 cycles or 6 months
Yes
Jared Weiss, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
LCCC 1210
NCT01702844
October 2012
June 2018
Name | Location |
---|---|
Rex Healthcare | Raleigh, North Carolina 27607 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Highlands Oncology Group | Springdale, Arkansas 72764 |
Cleveland Clinic | Cleveland, Ohio 44195 |
UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina |