NCT01063283

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Non-squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed 500 mg/m\^2 intravenously over 10 minutes
DRUG	Carboplatin	Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes
DRUG	Bevacizumab 7.5 mg/kg	Bevacizumab at 7.5 mg/kg intravenously over 90 minutes
DRUG	Bevacizumab 15 mg/kg	Bevacizumab at 15 mg/kg intravenously over 90 minutes

Timeline

• Start date: 2010-03-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2010-02-05
• Last updated: 2019-11-18
• Results posted: 2019-11-18

Locations

3 sites across 1 country: United States