NCT01702844

Single Arm on the Tolerability of Weekly Nab-paclitaxel

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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).

Conditions

• Non Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Nab-Paclitaxel	Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15

Timeline

• Start date: 2013-06-25
• Primary completion: 2017-06-23
• Completion: 2019-07-12
• First posted: 2012-10-08
• Last updated: 2020-10-08
• Results posted: 2020-10-08

Locations

8 sites across 1 country: United States