A Randomized, Open-Label, Dose Escalation Study of Bevacizumab With Ambulatory Blood Pressure Monitoring in Previously Untreated Patients With Advanced Non-squamous Non-Small Cell Lung Cancer
- Patients must have histologically or cytologically confirmed, newly diagnosed Stage
IIIB, stage IV, or recurrent non-squamous NSCLC for which they have not received
- Patients must have completed radiation therapy 2 weeks prior to enrollment. Patients
may have received adjuvant therapy, provided the regimen included no more than one of
the study agents.
- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension.
- Age >18 years. •Life expectancy of greater than 4 months.
- ECOG performance status of 0 or 1
- Patients must have normal organ and marrow function
- Patients on anticoagulation are allowed.
- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent
- Patients who have had received prior chemotherapy (in the setting of recurrent
disease, other than their original adjuvant therapy)
- Patients may not be receiving any other investigational agents.
- Patients with histologic evidence of predominantly squamous lung cell cancer
- General Medical Exclusions
- Inability to comply with study and/or follow-up procedures
- Malignancy other than superficial basal cell and superficial squamous of the skin or
carcinoma in situ of the cervix within last five years
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Known CNS disease, except for treated brain metastasis.
- Significant vascular disease within 6 months prior to Day 1
- History of hemoptysis within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 or anticipation of need for major surgical procedure during the course
of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1
- History of diverticulitis, abdominal fistula or gastrointestinal perforation within 6
months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria as demonstrated by a UPC ratio 1.0 at screening
- Known hypersensitivity to any component of bevacizumab
- Pregnancy (positive pregnancy test) or lactation.
- Mixed tumors will be categorized by the predominant cell type unless small cell
elements are present.
- Uncontrolled intercurrent illness including, ongoing or active infection or
psychiatric illness/social situations that would limit compliance with study
- Any unstable condition that in the opinion of the investigator is likely to interfere
with collection of accurate blood pressure measurement data .
- HIV-positive patients on combination antiretroviral therapy.