Clinical Trials /

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

NCT01620190

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 7755
  • SECONDARY ID: NCI-2012-00865
  • SECONDARY ID: 7755
  • SECONDARY ID: P30CA015704
  • NCT ID: NCT01620190

Conditions

  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IV Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Paclitaxel Albumin-Stabilized Nanoparticle FormulationABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, nab-paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, protein-bound paclitaxelTreatment (paclitaxel albumin-stabilized nanoparticle formula)

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (paclitaxel albumin-stabilized nanoparticle formula)ExperimentalPatients 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.
  • Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (complete and partial response) defined by RECIST 1.1 criteria
Time Frame:Up to 4 years
Safety Issue:
Description: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

Measure:Overall percentage of patients experiencing toxicity within a clinically significant category (neutropenia, neutropenic fever, or neuropathy)
Time Frame:Up to 30 days post-treatment
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Time elapsed from date of informed consent, until death, assessed up to 4 years
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description:
Measure:Time to progression
Time Frame:From the date of informed consent until the first documentation of progressive disease, assessed up to 4 years
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:University of Washington

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