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

NCT01063283 | Completed Results DMC

• 1 other identifier: 10-014-B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Non-squamous Non-Small Cell Lung Cancer

Keywords

Non-squamous Non-Small Cell Lung Cancer; Bevacizumab; Ambulatory Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• Change in 24 Hour Diastolic Blood Pressure (DBP)

  The change for each patient was calculated as mean 24 hour DBP during cycle 2 - mean 24 hour DBP during cycle 1

  2 cycles

Secondary Outcomes (3)

• Response Rate

  2 years

• Change in Tumor Size From Baseline

  2 years

• Progression Free Survival

  2 years

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Pemetrexed; Drug: Carboplatin; Drug: Bevacizumab 7.5 mg/kg

Group B

ACTIVE COMPARATOR

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

Drug: Pemetrexed; Drug: Carboplatin; Drug: Bevacizumab 7.5 mg/kg; Drug: Bevacizumab 15 mg/kg

Interventions

Pemetrexed DRUG

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

Group A; Group B

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

Group A; Group B

Bevacizumab 7.5 mg/kg DRUG

Bevacizumab at 7.5 mg/kg intravenously over 90 minutes

Group A; Group B

Bevacizumab 15 mg/kg DRUG

Bevacizumab at 15 mg/kg intravenously over 90 minutes

Group B

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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
• 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

Sponsors & Collaborators

• University of Chicago: lead
• Genentech, Inc.: collaborator

Study Sites (3)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

MeSH Terms

Interventions

Pemetrexed; Carboplatin; Bevacizumab

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Limitations and Caveats

Recruitment was slow and the study did not meet its accrual goals.

Results Point of Contact

• Title: Michael Maitland, MD, PhD
• Organization: Inova

Michael.Maitland@inova.org

571-472-4724

Study Officials

• Michael Maitland, MD., Ph.d

  The University of Chicago Medical Center

  PRINCIPAL INVESTIGATOR

• Michael Maitland, MD., PhD

  The University of Chicago Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 5, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Locations

US (3)