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

This study is currently recruiting participants.
Verified March 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01620190
First received: June 13, 2012
Last updated: March 10, 2014
Last verified: March 2014

June 13, 2012
March 10, 2014
November 2012
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01620190 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Assessed up to 2 years ] [ Designated as safety issue: Yes ]
  • Overall percentage of patients experiencing toxicity within a clinically significant category (neutropenia, neutropenic fever, or neuropathy) [ Time Frame: Assessed up to 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
A Phase II Study of Weekly Abraxane® (Nab-Paclitaxel) for Patients With Advanced NSCLC With EGFR Mutations Following Front-Line Therapy With EGFR Tyrosine Kinase Inhibitors

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • 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
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.
Interventions:
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
29
Not Provided
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in tumor deoxyribonucleic acid (DNA)
  • 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 =< 1.5mg/dL
  • Creatinine =< 1.5mg/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
Both
18 Years and older
No
Not Provided
United States
 
NCT01620190
7755, NCI-2012-00865, 7755, P30CA015704
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Christina Baik Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP