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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


N/A
18 Years
89 Years
Open (Enrolling)
Both
Advanced Non-squamous Non-Small Cell Lung Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Does a higher dose of bevacizumab have any effect on changes in blood pressure

Outcome Time Frame:

2 cycles

Safety Issue:

Yes

Principal Investigator

Michael Maitland, MD., Ph.d

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Chicago Medical Center

Authority:

United States: Institutional Review Board

Study ID:

10-014-B

NCT ID:

NCT01063283

Start Date:

March 2010

Completion Date:

March 2014

Related Keywords:

  • Advanced Non-squamous Non-Small Cell Lung Cancer
  • Non-squamous Non-Small Cell Lung Cancer
  • Bevacizumab
  • Ambulatory Blood Pressure Monitoring
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

The University of Chicago Medical CenterChicago, Illinois  60637-1470