Open-label, phase 2, single-arm, multi-center study of bevacizumab in combination with
gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung
cancer (NSCLC).
Inclusion Criteria
- Age 18 or higher
- Life expectancy of at least 3 months
- ECOG Performance status 0 to 1
- Advanced stage non-small cell lung cancer, NSCLC, Stage IIIB with malignant pleural
effusion or Stage IV, excluding squamous cell histology, with measurable or evaluable
disease
- No prior systemic therapy for advanced NSCLC (prior therapy for early stage disease
with one regimen is acceptable if it was completed at least 6 months prior to study
entry)
- Palliative radiotherapy to painful bony metastases is permitted prior to study entry
if completed prior to initiation of study treatment, and there are no residual
sequelae of therapy such as bone marrow suppression
- Willingness to use appropriate contraception to avoid pregnancy during the study
(female patient or female partner of a male patient)
- Leukocytes ≥ 3,000/µL
- Absolute neutrophil count ≥ 1,500/ µL
- Platelets ≥ 100,000/ µL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤ 2. 5 x institutional upper limit of normal
- Creatinine:
- Within normal institutional limits
- OR
- Creatinine clearance ≥ 60 mL/min/1. 73 m2 for patients with creatinine
levels above institutional normal
- Ability to sign informed consent
Exclusion Criteria:
- Prior systemic treatment for advanced NSCLC (one prior regimen of up to 4 cycles of
neoadjuvant or adjuvant therapy for early stage disease will be allowed, if completed
at least 6 months prior to study entry)
- Known brain metastases
- Prior treatment with bevacizumab
- History of allergic reactions or sensitivity attributed to compounds of similar
chemical or biologic composition to bevacizumab
- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in any other experimental drug study
- Concomitant chemotherapy, radiotherapy, or investigational agents
- Evidence of bleeding diathesis or coagulopathy
- Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs
- Pregnant (positive pregnancy test) or lactating
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to day 0
- Urine protein: creatinine ratio ≥ 1. 0 at screening
- History of abdominal fistula; gastrointestinal perforation; or intra-abdominal
abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Lung carcinoma of squamous cell histology or any histology in close proximity to a
major vessel, or with significant cavitation as assessed by treating investigator in
consultation with an attending radiologist
- History of hemoptysis (bright red blood of 1/2 teaspoon or more)
- Blood pressure of > 150/100 mmHg
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease
- Psychiatric illness/social situations that would limit compliance with study
requirements
- Another active malignancy except for non-melanoma skin cancers
- Inability to comply with study and/or follow-up procedures
