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Dose Escalation of Bevacizumab With Ambulatory Blood Pressure Monitoring in Patients With Advanced Non-squamous NSCLC (AVF4759)

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ClinicalTrials.gov Identifier: NCT01063283
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Non-squamous Non-Small Cell Lung Cancer Drug: Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg Drug: Carboplatin and Pemetrexed with Bevacizumab 15 mg/kg Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2010
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
 Drug: Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg
Carboplatin and Pemetrexed with Bevacizumab 7.5 mg/kg and bevacizumab every 3 weeks for two doses
Other Name: Carboplatin and Pemetrexed with Bevacizumab
Active Comparator: Group B
Carboplatin and Pemetrexed with Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses
 Drug: Carboplatin and Pemetrexed with Bevacizumab 15 mg/kg
Carboplatin and Pemetrexed with Bevacizumab 15 mg/kg and bevacizumab every 3 weeks for two doses
Other Name: Carboplatin and Pemetrexed with Bevacizumab


Outcome Measures
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Primary Outcome Measures :
  1. Does a higher dose of bevacizumab have any effect on changes in blood pressure [ Time Frame: 2 cycles ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 2 years ]
  2. Change in tumor size [ Time Frame: 2 years ]
  3. Progression free survival [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063283


Locations
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
North Shore University Health System
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Sponsors and Collaborators
University of Chicago
Genentech, Inc.
Investigators
Principal Investigator: Michael Maitland, MD., Ph.d The University of Chicago Medical Center
Principal Investigator: Michael Maitland, MD., PhD The University of Chicago Medical Center
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01063283     History of Changes
Other Study ID Numbers: 10-014-B
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by University of Chicago:
Non-squamous Non-Small Cell Lung Cancer
Bevacizumab
Ambulatory Blood Pressure Monitoring

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Carboplatin
 Pemetrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors