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

NCT00318136 | Completed Phase 2 Results

• 1 other identifier: AVF3744g
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Keywords

BRIDGE; NSCLC; Lung Cancer; Avastin

Outcome Measures

Primary Outcomes (1)

• 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."

  First bevacizumab administration until 60 days after discontinuation of bevacizumab or death

Secondary Outcomes (3)

• Selected Adverse Events

  First bevacizumab administration until 60 days after discontinuation of bevacizumab or death

• Adverse Events That Led to Discontinuation of Bevacizumab

  First bevacizumab administration until 60 days after discontinuation of bevacizumab or death

• Progression-free Survival

  Length of study

Study Arms (1)

Treated with Bevacizumab

EXPERIMENTAL

Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Bevacizumab DRUG

15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3

Treated with Bevacizumab

Carboplatin DRUG

Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles

Treated with Bevacizumab

Paclitaxel DRUG

Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles

Treated with Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Leonardo Faoro, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 26, 2006
• Study Start: September 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 11, 2010
• Results First Posted: April 6, 2010

Record last verified: 2010-05