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
Results First Posted : November 18, 2019
Last Update Posted : November 18, 2019
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Condition or disease | Intervention/treatment | Phase |
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Advanced Non-squamous Non-Small Cell Lung Cancer | Drug: Pemetrexed Drug: Carboplatin Drug: Bevacizumab 7.5 mg/kg Drug: Bevacizumab 15 mg/kg | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 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 |

Arm | Intervention/treatment |
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Active Comparator: Group A
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
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Drug: Pemetrexed
Pemetrexed 500 mg/m^2 intravenously over 10 minutes Drug: Carboplatin Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes Drug: Bevacizumab 7.5 mg/kg Bevacizumab at 7.5 mg/kg intravenously over 90 minutes |
Active Comparator: Group B
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
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Drug: Pemetrexed
Pemetrexed 500 mg/m^2 intravenously over 10 minutes Drug: Carboplatin Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes Drug: Bevacizumab 7.5 mg/kg Bevacizumab at 7.5 mg/kg intravenously over 90 minutes Drug: Bevacizumab 15 mg/kg Bevacizumab at 15 mg/kg intravenously over 90 minutes |
- Change in 24 Hour Diastolic Blood Pressure (DBP) [ Time Frame: 2 cycles ]The change for each patient was calculated as mean 24 hour DBP during cycle 2 - mean 24 hour DBP during cycle 1
- Response Rate [ Time Frame: 2 years ]Percentage of patients with a complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Change in Tumor Size From Baseline [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]Time to progression or death from any cause, whichever comes first

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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 |
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.
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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.

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
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 |
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 |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT01063283 |
Other Study ID Numbers: |
10-014-B |
First Posted: | February 5, 2010 Key Record Dates |
Results First Posted: | November 18, 2019 |
Last Update Posted: | November 18, 2019 |
Last Verified: | October 2019 |
Non-squamous Non-Small Cell Lung Cancer Bevacizumab Ambulatory Blood Pressure Monitoring |
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 Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |