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Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Washington
Information provided by (Responsible Party):
University of Washington Identifier:
First received: June 13, 2012
Last updated: November 26, 2014
Last verified: November 2014

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 advanced lung cancer and epidermal growth factor receptor (EGFR) mutations.

Condition Intervention Phase
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Weekly Abraxane for Patients With Advanced NSCLC With EGFR Mutations or With Durable Response to an EGFR Tyrosine Kinase Inhibitor Following Front Line Therapy With EGFR Tyrosine Kinase Inhibitors

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Overall response rate (complete and partial response) defined by RECIST 1.1 criteria [ Time Frame: Assessed up to 2 years ] [ Designated as safety issue: No ]
    The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.

Secondary Outcome Measures:
  • Time to progression [ Time Frame: From the date of informed consent until the first documentation of progressive disease, assessed up to 2 years ] [ Designated as safety issue: No ]
    Will report as median values with their respective 95% confidence intervals will be reported. Time to event distribution will be estimated using the Kaplan-Meier method.

  • Overall survival [ Time Frame: Time elapsed from date of informed consent, until death, assessed up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of patients experiencing grade 3 or higher toxicity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
  • Overall percentage of patients experiencing toxicity within a clinically significant category (neutropenia, neutropenic fever, or neuropathy) [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 29
Study Start Date: November 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (paclitaxel albumin-stabilized nanoparticle formula)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


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).


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.


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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in tumor deoxyribonucleic acid (DNA) or complete/partial response to first line EGFR tyrosine kinase inhibitors with > or = to 6 months duration of response in patients who do not have a confirmed EGFR mutation
  • At least one site of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Progressive disease with radiographic evidence of disease progression per investigator assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic setting; patients may continue EGFR inhibitor therapy throughout the screening period until the day prior to nab-paclitaxel treatment initiation
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at the time of informed consent
  • Platelet count >= 100,000/UL
  • Absolute neutrophil count >= 1,500/UL
  • Hemoglobin >= 9 g/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 2.5 times upper limit of normal
  • Bilirubin =< 1.5 mg/dL
  • Creatinine =< 1.5 mg/dL
  • Women of child-bearing potential (WOCP) and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, during treatment and for three months after completing treatment
  • Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
  • Life expectancy of > 12 weeks
  • Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

  • Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence
  • A single dose of a platinum doublet discontinued due to intolerability without evidence of disease progression is permitted
  • Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
  • Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment with surgery, radiation or both; in addition, they must be off corticosteroids
  • Radiotherapy within 7 days of study treatment
  • Peripheral neuropathy grade 2 or greater
  • Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA) criteria, or myocardial infarction within 6 months
  • Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
  • Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis
  • Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
  • Pregnant or breast feeding females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01620190

United States, Alaska
Anchorage Oncology Centre Recruiting
Anchorage, Alaska, United States, 99508
Contact: Latha Subramanian    907-569-2627      
Principal Investigator: Latha Subramanian         
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
Contact: Jeanne Anderson    907-562-0321      
Principal Investigator: Jeanne Anderson         
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Roy Davis    907-212-3629      
Principal Investigator: Jeanne Anderson         
United States, Montana
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Spencer Green    406-585-5070      
Principal Investigator: Jack Hensold         
United States, Washington
Columbia Basin Hematology and Oncology PLLC Recruiting
Kennewick, Washington, United States, 99336
Contact: Heather Johansen    509-783-4637 ext 1      
Principal Investigator: Thomas Rado         
Skagit Valley Hospital Recruiting
Mount Vernon, Washington, United States, 98274
Contact: Richard J. Abbott    360-428-8450      
Principal Investigator: Kiarash Kojouri         
Olympic Medical Center Recruiting
Port Angeles, Washington, United States, 98362
Contact: Eric Lewis    360-417-7705      
Principal Investigator: Thomas Kummet         
Group Health Cooperative Recruiting
Redmond, Washington, United States, 98052
Contact: Josephine Faust    206-225-7893      
Principal Investigator: Eric Chen         
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Christina S. Baik    206-288-7557      
Principal Investigator: Christina S. Baik         
Multicare Health System Recruiting
Tacoma, Washington, United States, 98415
Contact: Kathy Smith    253-403-1030      
Principal Investigator: John Rieke         
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801
Contact: Jay Johnson    509-663-8711      
Principal Investigator: Mitchell Garrison         
Sponsors and Collaborators
University of Washington
Principal Investigator: Christina Baik Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington Identifier: NCT01620190     History of Changes
Other Study ID Numbers: 7755, NCI-2012-00865, 7755, P30CA015704
Study First Received: June 13, 2012
Last Updated: November 26, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on March 03, 2015