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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 July 2016 by University of Washington
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01620190
First received: June 13, 2012
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
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: Up to 4 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:
  • 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 ]
  • Overall survival [ Time Frame: Time elapsed from date of informed consent, until death, assessed up to 4 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 Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: From the date of informed consent until the first documentation of progressive disease, assessed up to 4 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.


Estimated Enrollment: 29
Study Start Date: November 2012
Estimated Primary Completion Date: June 2017 (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.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
Other Names:
  • ABI 007
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • Albumin-Stabilized Nanoparticle Paclitaxel
  • nab-paclitaxel
  • Nanoparticle Albumin-bound Paclitaxel
  • Nanoparticle Paclitaxel
  • protein-bound paclitaxel

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 as determined by the Investigator, using 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
  • Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
  • 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 ClinicalTrials.gov identifier: NCT01620190

Locations
United States, Alaska
Anchorage Oncology Centre Terminated
Anchorage, Alaska, United States, 99508
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
Contact: Jeanne E. Anderson    907-562-0321      
Principal Investigator: Jeanne E. Anderson         
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Roy Davis    907-212-3629      
Principal Investigator: Jeanne E. Anderson         
United States, Montana
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Spencer Green    406-585-5070      
Principal Investigator: Jack O. Hensold         
United States, Washington
Kadlec Clinic Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Heather Johansen    509-783-4637 ext 1      
Principal Investigator: Thomas A. 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 Terminated
Port Angeles, Washington, United States, 98362
Group Health Cooperative Recruiting
Redmond, Washington, United States, 98052
Contact: Josephine Faust    206-225-7893      
Principal Investigator: Eric Y. Chen         
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Christina S. Baik    206-288-7557    cbaik2@uw.edu   
Principal Investigator: Christina S. Baik         
Spokane Valley Cancer Center-Mission Recruiting
Spokane, Washington, United States, 99216
Contact: Arvind Chaudhry    509-462-2273    achaudhry@spokanecyberknife.com   
Principal Investigator: Arvind Chaudhry         
Multicare Health System Recruiting
Tacoma, Washington, United States, 98415
Contact: Kathy D. Smith    253-403-1030      
Principal Investigator: John W. Rieke         
Wenatchee Valley Hospital and Clinics Recruiting
Wenatchee, Washington, United States, 98801
Contact: Jay Johnson    509-663-8711      
Principal Investigator: Lindsay C. Overton         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christina Baik Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01620190     History of Changes
Other Study ID Numbers: 7755  NCI-2012-00865  7755  P30CA015704 
Study First Received: June 13, 2012
Last Updated: July 25, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016