Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Pre-surgical Treatment with Bevacizumab plus Chemotherapy; Drug: Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab

• Registration Number: NCT00130780
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-16
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-12
• Results First Submitted: 2015-12-18
• Results First Submitted QC: 2015-12-18
• Last Update Submitted: 2015-12-18
• Results First Posted: 2016-01-25
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• 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%
• 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).

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Exclusion Criteria

• 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).
• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Pre-surgical Treatment with Bevacizumab plus Chemotherapy	Pre-surgical Treatment with Bevacizumab plus Chemotherapy
B	Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab	Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab

Primary Outcome Measures

Name	Time	Method
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.	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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States