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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00318136
First received: April 24, 2006
Last updated: May 5, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ] [ Designated as safety issue: No ]
    Any treatment-emergent adverse event leading to study treatment discontinuation

  • Progression-free Survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

    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.



Enrollment: 47
Study Start Date: September 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated with Bevacizumab Drug: Bevacizumab
15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3
Drug: Carboplatin
Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
Drug: Paclitaxel
Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318136

Sponsors and Collaborators
Genentech
Investigators
Study Director: Leonardo Faoro, M.D. Genentech
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00318136     History of Changes
Other Study ID Numbers: AVF3744g
Study First Received: April 24, 2006
Results First Received: March 19, 2010
Last Updated: May 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
BRIDGE
NSCLC
Lung Cancer
Avastin

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014