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Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pazopanib plus Paclitaxel
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, Pazopanib, Stage IIIB/IV non small cell lung cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are permitted. Palliative radiation therapy must have ended 14 days prior to first dose of pazopanib. Subject with recurrence after previous NSCLC that has been treated with surgery with or without adjuvant chemotherapy/radiation for curative intent are eligible, provided 12 months have passed since this treatment ended.

Exclusion Criteria:

  • Appropriate for doublet therapy as first line therapy. At discretion of investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pazopanib plus Paclitaxel

    Arm Description

    Pazopanib daily and weekly Paclitaxel IV.

    Outcomes

    Primary Outcome Measures

    Objective response rate of pazopanib in combination with paclitaxel
    The count of individuals who sustain a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during two years of treatment will be reported. A CR or PR response will be defined using standard RECIST criteria (version 1.1).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2010
    Last Updated
    October 10, 2016
    Sponsor
    Loyola University
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01179269
    Brief Title
    Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer
    Official Title
    Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was stopped because the research team was unable to enroll any participants
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Loyola University
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Lung cancer is the leading cause of cancer worldwide with approximately 1.2 million new cases each year. Non-small cell lung cancer (NSCLC) accounts for greater than 80% of all lung carcinomas in Western countries. Surgical resection is the treatment of choice for patients with early stage disease (Stage I and II), but at least 50% of these patients will relapse locally and/or develop distant metastases. Furthermore, 70% of patients with NSCLC are non-resectable at the time of their diagnosis due to either locally advanced or metastatic disease. The long-term prognosis for patients with NSCLC remains poor with the overall 5-year survival rate less than 15%. The low survival rate may be attributed to the high incidence of unresectable disease at presentation and the inability of systemic therapy to cure metastatic disease. There is a clear need for improvement in the treatment of NSCLC.
    Detailed Description
    The primary objective of this study is to evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1). A subject is defined as a responder if he/she sustains a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during treatment. A subject without a post-baseline assessment of response will be considered a non-responder. A secondary objective of this study is to evaluate the safety and tolerability of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), exposure, withdrawals due to AEs, dose reductions or interruptions, and changes from baseline in vital signs and clinical laboratory parameters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-small Cell Lung Cancer
    Keywords
    Non-small cell lung cancer, Pazopanib, Stage IIIB/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
    Pazopanib plus Paclitaxel
    Arm Type
    Experimental
    Arm Description
    Pazopanib daily and weekly Paclitaxel IV.
    Intervention Type
    Drug
    Intervention Name(s)
    Pazopanib plus Paclitaxel
    Intervention Description
    Pazopanib daily and weekly paclitaxel IV
    Primary Outcome Measure Information:
    Title
    Objective response rate of pazopanib in combination with paclitaxel
    Description
    The count of individuals who sustain a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during two years of treatment will be reported. A CR or PR response will be defined using standard RECIST criteria (version 1.1).
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are permitted. Palliative radiation therapy must have ended 14 days prior to first dose of pazopanib. Subject with recurrence after previous NSCLC that has been treated with surgery with or without adjuvant chemotherapy/radiation for curative intent are eligible, provided 12 months have passed since this treatment ended. Exclusion Criteria: Appropriate for doublet therapy as first line therapy. At discretion of investigator.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Danielle Shafer, DO
    Organizational Affiliation
    Loyola University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Cheryl Czerlanis, MD
    Organizational Affiliation
    Loyola University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer

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