Advanced Non-squamous Non-Small Cell Lung CancerAVF4759NCT01063283
Dose Escalation of Bevacizumab With Ambulatory Blood Pressure Monitoring in Patients With Advanced Non-squamous NSCLC
A study testing Pemetrexed, Carboplatin and Bevacizumab 7.5 mg/kg in people with Advanced Non-squamous Non-Small Cell Lung Cancer, run by University of Chicago at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Advanced Non-squamous Non-Small Cell Lung Cancer
- What is being tested?
- Pemetrexed, Carboplatin and Bevacizumab 7.5 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Chicago Medical Center
Chicago, Illinois, 60637
North Shore University Health System
Evanston, Illinois, 60201
Ingalls Memorial Hospital
Harvey, Illinois, 60426
About this study
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
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.
Read the 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.
- Being tested
- Pemetrexed, Carboplatin, Bevacizumab 7.5 mg/kg, Bevacizumab 15 mg/kg
- Keywords
- Non-squamous Non-Small Cell Lung Cancer, Bevacizumab, Ambulatory Blood Pressure Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Pemetrexed 500 mg/m^2 intravenously over 10 minutes
CarboplatinDrug
Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes
Bevacizumab 7.5 mg/kgDrug
Bevacizumab at 7.5 mg/kg intravenously over 90 minutes
Bevacizumab 15 mg/kgDrug
Bevacizumab at 15 mg/kg intravenously over 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 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 Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: Bevacizumab 7.5 mg/kg |
| Group B | Active comparator | 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 Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: Bevacizumab 7.5 mg/kg; Drug: Bevacizumab 15 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24 Hour Diastolic Blood Pressure (DBP)
The change for each patient was calculated as mean 24 hour DBP during cycle 2 - mean 24 hour DBP during cycle 1
Measured: 2 cycles
Secondary outcomes (3)
Response Rate
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.
Measured: 2 years
Change in Tumor Size From Baseline
Measured: 2 years
Progression Free Survival
Time to progression or death from any cause, whichever comes first
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Non-squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Maitland, MD., Ph.d, Principal investigator, The University of Chicago Medical CenterMichael Maitland, MD., PhD, Principal investigator, The University of Chicago Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063283
- Sponsor's protocol ID
- 10-014-B
- Acronym
- AVF4759
- Status last verified
- Oct 2019
- First submitted
- 3 Feb 2010
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01063283
- Acronym / sponsor ID
- AVF4759 / 10-014-B
- Keywords
- Non-squamous Non-Small Cell Lung Cancer, Bevacizumab, Ambulatory Blood Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Mar 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Pemetrexed, Drug: Carboplatin, Drug: Bevacizumab 7.5 mg/kgCarboplatin 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 |
| Group B | Active comparator | Drug: Pemetrexed, Drug: Carboplatin, Drug: Bevacizumab 7.5 mg/kg, Drug: Bevacizumab 15 mg/kgCarboplatin 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (28 listed)
- 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
- Inability to comply with study and/or follow-up procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedPemetrexed 500 mg/m^2 intravenously over 10 minutes | Drug | Group A, Group B |
| CarboplatinCarboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes | Drug | Group A, Group B |
| Bevacizumab 7.5 mg/kgBevacizumab at 7.5 mg/kg intravenously over 90 minutes | Drug | Group A, Group B |
| Bevacizumab 15 mg/kgBevacizumab at 15 mg/kg intravenously over 90 minutes | Drug | Group B |
Primary outcome
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
3 secondary outcomes
Response Rate
Time frame: 2 years
Change in Tumor Size From Baseline
Time frame: 2 years
Progression Free Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Maitland, MD., Ph.d principal investigator
The University of Chicago Medical Center
Michael Maitland, MD., PhD principal investigator
The University of Chicago Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pemetrexed, Carboplatin and Bevacizumab 7.5 mg/kg in people with Advanced Non-squamous Non-Small Cell Lung Cancer, run by University of Chicago at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24 Hour Diastolic Blood Pressure (DBP) (time frame: 2 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.