Carcinoma, Non-Small-Cell LungPhase 2NCT00130780
Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC
A Phase 2 study testing Pre-surgical Treatment with Bevacizumab plus Chemotherapy and Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab in people with Carcinoma, Non-Small-Cell Lung, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is a phase II, single institution trial for patients with clinical Stage IB-IIIA NSCLC (T1-3N0-2M0) who have resectable lung tumors. The primary goal of this study is to show that the addition of bevacizumab to a cisplatin-based chemotherapy in the neoadjuvant setting for non-squamous cell carcinomas improves the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Pre-surgical Treatment with Bevacizumab plus Chemotherapy and Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Oct 2012
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic confirmation of NSCLC at Memorial Sloan-Kettering Cancer Center (MSKCC)
- Stages IB, IIA, IIB or IIIA (T1-3N0-2M 0) NSCLC
- Patients must be candidates for resection with curative intent.
- Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions
- Age >= 18 years
- Karnofsky performance status >= 70%
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- Normal marrow function: leukocytes >= 3,000/µl; absolute neutrophil count ≥ 1,500µl; platelets >= 100,000 µl; hemoglobin >= 9gm/dl.
- Adequate renal function, with creatinine <= 1.3 mg/dl or calculated creatinine clearance >= 60ml/min by Cockcroft-Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
- Adequate hepatic function: total bilirubin within normal limits; AST <= 1.5 X upper limit of normal (UNL); ALT <= 1.5 X UNL; alkaline phosphatase <= 1.5 X UNL.
- Women of childbearing age must have a negative urine or blood pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
- Eligibility criteria for group B: Patients with SQUAMOUS CELL carcinoma or patients with a NON-SQUAMOUS CELL tumor with a large central tumor in proximity to significant blood vessels or any history of hemoptysis will be assigned to group B (preoperative chemotherapy alone without bevacizumab).
Who cannot join
- Prior chemotherapy or radiation therapy for NSCLC
- Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
- Patients with a history of severe hypersensitivity reaction to docetaxel (Taxotere) or other drugs formulated with polysorbate 80
- Patients with known hypersensitivity to other recombinant human antibodies
- Patients must not be receiving any other investigational agents.
- History of stroke or transient ischemic attack (TIA).
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- History of myocardial infarction or unstable angina within the past 12 months.
- Patients who report a hearing deficit at baseline, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or higher)
- Peripheral neuropathy > grade 1.
- Uncontrolled hypertension
- Esophageal varices, non-healing ulcer, wound, or bone fracture
- Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs.
- Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
- Women who are pregnant or breast-feeding
- Psychiatric illness or social situation that would limit compliance with study requirements
- Exclusion criteria for group A: Patients with SQUAMOUS CELL carcinoma, large central tumor in proximity to significant blood vessels, or any history of hemoptysis (will be excluded from group A (preoperative chemotherapy plus bevacizumab); these patients will be assigned to group B (preoperative chemotherapy).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) (BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC)
This is a phase II, single institution trial for patients with clinical Stage IB-IIIA NSCLC (T1-3N0-2M0) who have resectable lung tumors. The primary goal of this study is to show that the addition of bevacizumab to a cisplatin-based chemotherapy in the neoadjuvant setting for non-squamous cell carcinomas improves the rate of pathologic downstaging, which correlates with survival. Downstaging is defined as any decrease in the final pathologic stage compared with the clinical stage before induction therapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Pre-surgical Treatment with Bevacizumab plus Chemotherapy, Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab
- Keywords
- Multi-modality treatment for lung cancer, Carcinoma, Squamous Cell, Bevacizumab, BEACON, 05-052
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-surgical Treatment with Bevacizumab plus ChemotherapyDrug
On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally 2 weeks after it is scheduled, if necessary.
Pre-Surgical Docetaxel and Cisplatin and Adjuvant BevacizumabDrug
Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally 2 weeks after it is scheduled, if necessary.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Pre-surgical Treatment with Bevacizumab plus Chemotherapy Receives: Drug: Pre-surgical Treatment with Bevacizumab plus Chemotherapy |
| B | Active comparator | Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab Receives: Drug: Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment.
These criteria have been modified for the purpose of this study (i.e.: there will be no confirmation of response at 4 weeks per usual response criteria as this is not applicable to the preoperative treatment plan): Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the meas
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 posted16 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2012
- Study completionOct 2012
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 Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naiyer Rizvi, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130780
- Sponsor's protocol ID
- 05-052
- Status last verified
- Dec 2015
- First submitted
- 12 Aug 2005
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) (BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC)
- ClinicalTrials.gov ID
- NCT00130780
- Acronym / sponsor ID
- 05-052
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Multi-modality treatment for lung cancer, Carcinoma, Squamous Cell, Bevacizumab, BEACON, 05-052
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Aug 2005 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, single institution trial for patients with clinical Stage IB-IIIA NSCLC (T1-3N0-2M0) who have resectable lung tumors. The primary goal of this study is to show that the addition of bevacizumab to a cisplatin-based chemotherapy in the neoadjuvant setting for non-squamous cell carcinomas improves the rate of pathologic downstaging, which correlates with survival. Downstaging is defined as any decrease in the final pathologic stage compared with the clinical stage before induction therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Pre-surgical Treatment with Bevacizumab plus ChemotherapyPre-surgical Treatment with Bevacizumab plus Chemotherapy |
| B | Active comparator | Drug: Pre-Surgical Docetaxel and Cisplatin and Adjuvant BevacizumabPre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologic confirmation of NSCLC at Memorial Sloan-Kettering Cancer Center (MSKCC)
- Stages IB, IIA, IIB or IIIA (T1-3N0-2M 0) NSCLC
- Patients must be candidates for resection with curative intent.
- Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions
- Age >= 18 years
Key exclusion criteria (16 listed)
- Prior chemotherapy or radiation therapy for NSCLC
- Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
- Patients with a history of severe hypersensitivity reaction to docetaxel (Taxotere) or other drugs formulated with polysorbate 80
- Patients with known hypersensitivity to other recombinant human antibodies
- Patients must not be receiving any other investigational agents.
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 |
|---|---|---|
| Pre-surgical Treatment with Bevacizumab plus ChemotherapyOn Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally 2 weeks after it is scheduled, if necessary. | Drug | A |
| Pre-Surgical Docetaxel and Cisplatin and Adjuvant BevacizumabPatients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally 2 weeks after it is scheduled, if necessary. | Drug | B |
Primary outcome
The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment.
Time frame: 2 years
These criteria have been modified for the purpose of this study (i.e.: there will be no confirmation of response at 4 weeks per usual response criteria as this is not applicable to the preoperative treatment plan): Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the meas
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Naiyer Rizvi, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pre-surgical Treatment with Bevacizumab plus Chemotherapy and Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab in people with Carcinoma, Non-Small-Cell Lung, run by Memorial Sloan Kettering Cancer Center at 1 site 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 13 inclusion and 16 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 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2016). 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?
The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment. (time frame: 2 years). 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 25 Jan 2016.