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

Completed · Not applicable

Conditions studied: Advanced Non-squamous Non-Small Cell Lung Cancer

In brief

The purpose of this study is to see if higher dose of bevacizumab can be taken safely by some patients and if changes in the dose of bevacizumab have any effect on blood pressure.

Key facts

Study ID

NCT01063283

Run by

University of Chicago

People needed

20

Starts

2010-03-01

Expected to finish

2016-06-01

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of Chicago Medical Center — Chicago, Illinois, United States
• North Shore University Health System — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States

Full record on ClinicalTrials.gov

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