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

NCT ID: NCT00318136

Last Updated: 2010-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-07-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treated with Bevacizumab

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: 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

Interventions

Bevacizumab

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Genentech, Inc.

Principal Investigators

Leonardo Faoro, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

AVF3744g

Identifier Type: -

Identifier Source: org_study_id