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

NCT ID: NCT01063283

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2016-06-30

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.

Conditions

Advanced Non-squamous Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

Pemetrexed 500 mg/m\^2 intravenously over 10 minutes

Carboplatin

Intervention Type: 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

Intervention Type: DRUG

Bevacizumab at 7.5 mg/kg intravenously over 90 minutes

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

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

Pemetrexed 500 mg/m\^2 intravenously over 10 minutes

Carboplatin

Intervention Type: 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

Intervention Type: DRUG

Bevacizumab at 7.5 mg/kg intravenously over 90 minutes

Bevacizumab 15 mg/kg

Intervention Type: DRUG

Bevacizumab at 15 mg/kg intravenously over 90 minutes

Interventions

Pemetrexed

Pemetrexed 500 mg/m\^2 intravenously over 10 minutes

Intervention Type: 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

Intervention Type: DRUG

Bevacizumab 7.5 mg/kg

Bevacizumab at 7.5 mg/kg intravenously over 90 minutes

Intervention Type: DRUG

Bevacizumab 15 mg/kg

Bevacizumab at 15 mg/kg intravenously over 90 minutes

Intervention Type: 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Maitland, MD., Ph.d

Role: PRINCIPAL_INVESTIGATOR

The University of Chicago Medical Center

Michael Maitland, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Chicago Medical Center

Locations

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

Countries

United States

Other Identifiers

10-014-B

Identifier Type: -

Identifier Source: org_study_id