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

Conditions

• Advanced Non-squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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 Dates

First listed

Feb 5, 2010

Start date

Mar 31, 2010

Status verified

Oct 2019

Primary completion

Jun 30, 2016

Completion

Jun 30, 2016

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Active Comparator: Group A
  Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
• Active Comparator: Group B
  Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg once, followed three weeks later by Carboplatin+Pemetrexed+Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses

Primary Outcome Measure

Change in 24 Hour Diastolic Blood Pressure (DBP) [ Time Frame: 2 cycles ]

Locations (3)

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