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

Genentech

Status and phase

Completed

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Bevacizumab

Drug: Paclitaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00318136

AVF3744g

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No 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