This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) in patients with lung cancer. Abraxane is a chemotherapy approved to treat patients with breast cancer. Doctors want to know if Abraxane is safe and effective in treating patients with lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor (EGFR) mutations.
PRIMARY OBJECTIVES: I. To evaluate the overall response rate of weekly nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations following front-line therapy with EGFR tyrosine kinase inhibitors (TKI). SECONDARY OBJECTIVES: I. To evaluate the safety profile of weekly nab-paclitaxel in patients with advanced NSCLC with EGFR mutations following front-line therapy with an EGFR TKI. II. To evaluate the time-to-progression and overall survival. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks and then every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Correlative studies
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Olympic Medical Center
Port Angeles, Washington, United States
Group Health Cooperative
Redmond, Washington, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Spokane Valley Cancer Center-Mission
Spokane, Washington, United States
...and 2 more locations
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.
Time frame: Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy.
Toxicity rates will be described as percentage of patient who experienced a Grade 3 or higher clinically significant toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time frame: Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
Overall Survival
Will report as median values with their respective 95% confidence intervals will be reported. Time to event distribution will be estimated using Kaplan-Meier method.
Time frame: Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.
Overall Percentage of Patients Experiencing Grade 3 or Higher Toxicity.
Toxicity rates will be described as percentage of patients experiencing Grade 3 or higher toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time frame: Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
Time to Progression.
Reported as median values with their respective 95% confidence intervals for patients who were assessed. Time to event distribution will be estimated using the Kaplan-Meier method.
Time frame: Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.