Clinical trial NCT01063283: Dose Escalation of Bevacizumab With Ambulatory Blood Pressure Monitoring in Patients With Advanced Non-squamous NSCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Non-squamous Non-Small Cell Lung Cancer
Keywords: Non-squamous Non-Small Cell Lung Cancer
Bevacizumab
Ambulatory Blood Pressure Monitoring
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Carboplatin and pemetrexed are FDA approved chemotherapy agents for patients with advanced non squamous non small cell lung cancer. Bevacizumab is also FDA approved in lung cancer , and the combination of all three drugs is promising. The doctors directing this research want to learn how to better personalize drug dosing of bevacizumab by identifying people who could safely take a higher dose of the drug.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in 24 Hour Diastolic Blood Pressure (DBP)
timeFrame: 2 cycles
Secondary outcomes:
measure: Response Rate
timeFrame: 2 years
measure: Change in Tumor Size From Baseline
timeFrame: 2 years
measure: Progression Free Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
Study officials:
affiliation: The University of Chicago Medical Center
name: Michael Maitland, MD., Ph.d
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Chicago Medical Center
name: Michael Maitland, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: