A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT00257608Tipo: INTERVENTIONALInicio: 1 de ene de 2006Fin estimado: 1 de nov de 2014

Traducción no disponible, mostrando original

Resumen

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Signed Informed Consent Form
Histologically or cytologically confirmed NSCLC
Advanced NSCLC or recurrent disease
INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within 28 days prior to enrollment for subjects not on low molecular weight heparin or fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin is not permitted.
years of age or older
For women of childbearing potential and sexually active men, use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to enrollment and for the duration of the study

Criterios de exclusión

Prior systemic chemotherapy in the metastatic setting
Treatment with an investigational or marketed agent that acts by either EGFR inhibition or anti-angiogenesis mechanisms
Pregnancy or lactation
Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
Active infection or a fever within 3 days of enrollment
Active malignancy other than lung cancer
Radiation therapy to sites other than whole brain within 14 days prior to enrollment
History of gross hemoptysis within 3 months prior to enrollment
Known hypersensitivity to any of the components of cytotoxic chemotherapy combinations, bevacizumab, or tyrosine kinase inhibitors
Inadequately controlled hypertension
Unstable angina or New York Heart Association Grade II or greater CHF
Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
History of myocardial infarction within 6 months prior to enrollment
History of stroke within 6 months prior to enrollment
Symptomatic peripheral vascular disease within 6 months prior to enrollment
Evidence of bleeding diathesis or coagulopathy
Serious, non-healing wound, ulcer, or bone fracture
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment; anticipation of need for major surgical procedure during the course of the study
Current, recent, or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab/erlotinib study
Progressive neurologic symptoms in subjects with a history of brain metastases
History of significant vascular disease (e.g., aortic aneurysm)

Intervenciones

drug

bevacizumab

Intravenous repeating dose

drug

placebo

Oral repeating dose

drug

erlotinib HCl

Oral repeating dose

Ubicaciones

Hospital Pirovano

Buenos Aires, Argentina

Hospital Britanico

Buenos Aires, Argentina

Hospital Toru

Buenos Aires, Argentina

CEMIC

Buenos Aires, Argentina

Centro Oncologico de Cordoba

Córdoba, Argentina

COIR

Mendoza, Argentina

Instituto Medico Privado

Resistencia, Argentina

Clinica Oncologica de Rosario

Rosario, Argentina

ISIS Clinica Especializada

Sante Fe, Argentina

Patrocinadores

PrincipalGenentech, Inc.

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