Clinical trial NCT00130780: Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC
Official title: Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) (BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Multi-modality treatment for lung cancer
Carcinoma, Squamous Cell
Bevacizumab
BEACON
05-052
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2005-08-16
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

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).

Primary outcomes:
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.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Naiyer Rizvi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: