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

This study is currently recruiting participants.
Verified March 2014 by University of Chicago
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01063283
First received: February 3, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Does a higher dose of bevacizumab have any effect on changes in blood pressure [ Time Frame: 2 cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in tumor size [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063283

Contacts
Contact: Michael Maitland, MD., PhD (773) 702 4400 mmaitlan@medicine.bsd.uchicago.edu
Contact: Mandira Ray, MD (773) 702 4400 mandira.ray@uchospitals.edu

Locations
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Michael Maitland, MD., Ph.D    773-702-4400    mmaitlan@medicine.bsd.uchicago.edu   
Contact: Mandira Ray, MD    (773) 702 4400    mandira.ray@uchospitals.edu   
Sub-Investigator: Philip Hoffman, M.D         
Sub-Investigator: Ravi Salgia, M.D., Ph.D         
Sub-Investigator: Victoria Villaflor, M.D.         
Sub-Investigator: Everett Vokes, M.D.         
Sponsors and Collaborators
University of Chicago
Genentech
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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01063283     History of Changes
Other Study ID Numbers: 10-014-B
Study First Received: February 3, 2010
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 22, 2014