Dose Escalation of Bevacizumab With Ambulatory Blood Pressure Monitoring in Patients With Advanced Non-squamous NSCLC (AVF4759)

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.