CompletedNot applicableNCT01063283

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

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.

Checked against the public recordLast updated Nov 18, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations3
SponsorUniversity of Chicago
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
University of Chicago
Interventions being studied
Drug: Pemetrexed; Drug: Carboplatin; Drug: Bevacizumab 7.5 mg/kg; Drug: Bevacizumab 15 mg/kg
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The University of Chicago Medical CenterChicago, Illinois
  • North Shore University Health SystemEvanston, Illinois
  • Ingalls Memorial HospitalHarvey, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 18, 2019. Always confirm current availability with the study team.

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