Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC
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).
You may not be if
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
Clareo Health | Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC
