Dose Escalation of Bevacizumab With Ambulatory Blood Pressure Monitoring in Patients With Advanced Non-squamous NSCLC

Inclusion Criteria:

Patients must have histologically or cytologically confirmed, newly diagnosed Stage IIIB, stage IV, or recurrent non-squamous NSCLC for which they have not received chemotherapy.
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 document.

Exclusion Criteria:

Disease-Specific

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

Bevacizumab-Specific Exclusions

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 requirements.
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.