Clinical trial NCT00318136: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: BRIDGE
NSCLC
Lung Cancer
Avastin
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-04-26
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events
timeFrame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Secondary outcomes:
measure: Selected Adverse Events
timeFrame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
measure: Adverse Events That Led to Discontinuation of Bevacizumab
timeFrame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
measure: Progression-free Survival
timeFrame: Length of study
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Leonardo Faoro, M.D.
role: STUDY_DIRECTOR
References: