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A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bevacizumab
Carboplatin
Paclitaxel
Sponsored by
Genentech, Inc.
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 BRIDGE, NSCLC, Lung Cancer, Avastin

Eligibility Criteria

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

Inclusion Criteria: Signed Informed Consent Form(s) At least 18 years of age Advanced histologically or cytologically confirmed predominant squamous NSCLC Subjects with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment of the brain metastasis/metastases Prior treatment for CNS disease as deemed appropriate by the treating physician ECOG performance status 0, 1, or 2 Measurable or evaluable disease Use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study (for women of childbearing potential and sexually active men) Exclusion Criteria: Prior chemotherapy for metastatic disease Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus radiotherapy) if < 6 months has elapsed from completion of treatment to Day 1, Cycle 1 Extrathoracic metastases as the only sites of disease Active malignancy other than lung cancer Current, recent, or planned participation in another experimental drug study Untreated brain metastases Presence of intrathoracic lesion(s) with any cavitation Gross hemoptysis within 3 months prior to Day 1 In the opinion of the investigator or local radiologist, evidence of tumor that is extending into the lumen of a major blood vessel Inadequately controlled hypertension Unstable angina or NYHA Grade II or greater CHF Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 Myocardial infarction within 6 months prior to Day 1, Cycle 1 Stroke within 6 months prior to Day 1, Cycle 1 Active symptomatic peripheral vascular disease within 6 months prior to Day 1, Cycle 1 History of significant vascular disease Evidence of bleeding diathesis or coagulopathy Current, ongoing treatment with full-dose warfarin or its equivalent Current or recent use of aspirin (>325 mg/day) Known hypersensitivity to any components of bevacizumab Serious, non-healing wound, ulcer, or bone fracture UPC ratio ≥ 1.0 Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of need for major surgical procedure during the course of the study Pregnancy or lactation Inadequate organ function Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treated with Bevacizumab

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events
    To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."

    Secondary Outcome Measures

    Selected Adverse Events
    Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions. Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting.
    Adverse Events That Led to Discontinuation of Bevacizumab
    Any treatment-emergent adverse event leading to study treatment discontinuation
    Progression-free Survival
    Progression-free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab. Summary of PFS (median) was estimated from Kaplan-Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.

    Full Information

    First Posted
    April 24, 2006
    Last Updated
    May 5, 2010
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00318136
    Brief Title
    A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)
    Official Title
    A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.

    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
    BRIDGE, NSCLC, Lung Cancer, Avastin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treated with Bevacizumab
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Intervention Description
    15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Description
    Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
    Primary Outcome Measure Information:
    Title
    Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events
    Description
    To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."
    Time Frame
    First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
    Secondary Outcome Measure Information:
    Title
    Selected Adverse Events
    Description
    Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions. Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting.
    Time Frame
    First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
    Title
    Adverse Events That Led to Discontinuation of Bevacizumab
    Description
    Any treatment-emergent adverse event leading to study treatment discontinuation
    Time Frame
    First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
    Title
    Progression-free Survival
    Description
    Progression-free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab. Summary of PFS (median) was estimated from Kaplan-Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.
    Time Frame
    Length of study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed Informed Consent Form(s) At least 18 years of age Advanced histologically or cytologically confirmed predominant squamous NSCLC Subjects with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment of the brain metastasis/metastases Prior treatment for CNS disease as deemed appropriate by the treating physician ECOG performance status 0, 1, or 2 Measurable or evaluable disease Use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study (for women of childbearing potential and sexually active men) Exclusion Criteria: Prior chemotherapy for metastatic disease Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus radiotherapy) if < 6 months has elapsed from completion of treatment to Day 1, Cycle 1 Extrathoracic metastases as the only sites of disease Active malignancy other than lung cancer Current, recent, or planned participation in another experimental drug study Untreated brain metastases Presence of intrathoracic lesion(s) with any cavitation Gross hemoptysis within 3 months prior to Day 1 In the opinion of the investigator or local radiologist, evidence of tumor that is extending into the lumen of a major blood vessel Inadequately controlled hypertension Unstable angina or NYHA Grade II or greater CHF Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 Myocardial infarction within 6 months prior to Day 1, Cycle 1 Stroke within 6 months prior to Day 1, Cycle 1 Active symptomatic peripheral vascular disease within 6 months prior to Day 1, Cycle 1 History of significant vascular disease Evidence of bleeding diathesis or coagulopathy Current, ongoing treatment with full-dose warfarin or its equivalent Current or recent use of aspirin (>325 mg/day) Known hypersensitivity to any components of bevacizumab Serious, non-healing wound, ulcer, or bone fracture UPC ratio ≥ 1.0 Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of need for major surgical procedure during the course of the study Pregnancy or lactation Inadequate organ function Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leonardo Faoro, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)

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