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Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
paclitaxel albumin-stabilized nanoparticle formulation
sunitinib malate
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IV disease
  • At least 1 measurable lesion as defined by modified RECIST criteria

  • No symptomatic or untreated brain metastases

    • Prior brain metastases allowed provided the CNS disease has been treated and is considered stable and the patient has recovered from the acute toxic effects of the treatment prior to study entry

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-1
  • WBC ≥ 3.0 x 10^9/L
  • ANC ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver has tumor involvement)
  • Creatinine ≤ 1.5 mg/dL
  • LVEF ≥ 40% by MUGA
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment

Exclusion criteria:

  • Congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 12 months
  • Ongoing severe or unstable angina
  • Unstable arrhythmia requiring medication
  • Sensory neuropathy ≥ grade 2 (according to NCI CTCAE v3.0)
  • Known hypersensitivity to any of the agents used in this study
  • Serious medical or psychiatric illness that, in the opinion of the enrolling investigator, is likely to interfere with study participation

PRIOR CONCURRENT THERAPY:

  • No prior systemic therapy for NSCLC
  • More than 4 weeks since prior major surgery

  • More than 7 days since prior and no concurrent potent CYP3A4 inhibitors, including any of the following:

    • Ketoconazole
    • Itraconazole
    • Clarithromycin
    • Erythromycin
    • Diltiazem
    • Verapamil
    • Delavirdine
    • Indinavir
    • Saquinavir
    • Ritonavir
    • Atazanavir
    • Nelfinavir

  • More than 12 days since prior and no concurrent potent CYP3A4 inducers, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • St. John's wort
    • Efavirenz
    • Tipranavir

  • No concurrent treatment with a drug having proarrhythmic potential, including any of the following:

    • Terfenadine
    • Quinidine
    • Procainamide
    • Disopyramide
    • Sotalol
    • Probucol
    • Bepridil
    • Haloperidol
    • Risperidone
    • Indapamide
    • Flecainide
  • No other concurrent investigational agents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Stage IV Non-Small Cell Lung Cancer Patients

    Arm Description

    Patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.

    Outcomes

    Primary Outcome Measures

    Response rate

    Secondary Outcome Measures

    Time to objective tumor response as assessed by RECIST criteria
    Duration of response
    Time to treatment failure
    Overall survival
    Toxicity and adverse events as assessed by NCI CTCAE v3.0

    Full Information

    First Posted
    September 5, 2008
    Last Updated
    August 6, 2018
    Sponsor
    Masonic Cancer Center, University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00748163
    Brief Title
    Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
    Official Title
    Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study has been abandoned for lack of available funding.
    Study Start Date
    August 2008 (Anticipated)
    Primary Completion Date
    August 2008 (Anticipated)
    Study Completion Date
    August 2008 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Masonic Cancer Center, University of Minnesota

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib works as first-line therapy in treating patients with stage IV non-small cell lung cancer.
    Detailed Description
    OBJECTIVES: Primary To determine the tumor response rate in patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy. Secondary To determine the time to objective tumor response and duration of response in responding patients. To determine the time to treatment failure and overall survival of these patients. To characterize the toxicities of this regimen in these patients. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks until disease progression and then every 3 months for up to 1 year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    stage IV non-small cell lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stage IV Non-Small Cell Lung Cancer Patients
    Arm Type
    Experimental
    Arm Description
    Patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    paclitaxel albumin-stabilized nanoparticle formulation
    Intervention Type
    Drug
    Intervention Name(s)
    sunitinib malate
    Primary Outcome Measure Information:
    Title
    Response rate
    Time Frame
    1 Year
    Secondary Outcome Measure Information:
    Title
    Time to objective tumor response as assessed by RECIST criteria
    Time Frame
    1 Year
    Title
    Duration of response
    Time Frame
    1 Year
    Title
    Time to treatment failure
    Time Frame
    1 Year
    Title
    Overall survival
    Time Frame
    1 Year
    Title
    Toxicity and adverse events as assessed by NCI CTCAE v3.0
    Time Frame
    1 Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IV disease At least 1 measurable lesion as defined by modified RECIST criteria No symptomatic or untreated brain metastases Prior brain metastases allowed provided the CNS disease has been treated and is considered stable and the patient has recovered from the acute toxic effects of the treatment prior to study entry PATIENT CHARACTERISTICS: Inclusion criteria: ECOG performance status 0-1 WBC ≥ 3.0 x 10^9/L ANC ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Bilirubin ≤ 1.5 mg/dL AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver has tumor involvement) Creatinine ≤ 1.5 mg/dL LVEF ≥ 40% by MUGA Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Exclusion criteria: Congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 12 months Ongoing severe or unstable angina Unstable arrhythmia requiring medication Sensory neuropathy ≥ grade 2 (according to NCI CTCAE v3.0) Known hypersensitivity to any of the agents used in this study Serious medical or psychiatric illness that, in the opinion of the enrolling investigator, is likely to interfere with study participation PRIOR CONCURRENT THERAPY: No prior systemic therapy for NSCLC More than 4 weeks since prior major surgery More than 7 days since prior and no concurrent potent CYP3A4 inhibitors, including any of the following: Ketoconazole Itraconazole Clarithromycin Erythromycin Diltiazem Verapamil Delavirdine Indinavir Saquinavir Ritonavir Atazanavir Nelfinavir More than 12 days since prior and no concurrent potent CYP3A4 inducers, including any of the following: Rifampin Rifabutin Carbamazepine Phenobarbital Phenytoin St. John's wort Efavirenz Tipranavir No concurrent treatment with a drug having proarrhythmic potential, including any of the following: Terfenadine Quinidine Procainamide Disopyramide Sotalol Probucol Bepridil Haloperidol Risperidone Indapamide Flecainide No other concurrent investigational agents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arkadiusz Dudek, MD
    Organizational Affiliation
    Masonic Cancer Center, University of Minnesota
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

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