A Phase II Study of Velcade® (Bortezomib) in Patients Stage IIIB OR IV Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Chemotherapy
Chemotherapy for non-small-cell lung cancer (NSCLC), mainly Cisplatin-based combinations,
provides a measurable but modest survival benefit for selected patients with advanced
disease. Advanced NSCLC remains largely fatal, with the positive impact of chemotherapy
limited by intrinsic and acquired resistance, manifested clinically by early progression and
transient responses. Current chemotherapy regimens have limited efficacy with a magnitude of
survival benefit that is still modest, and lead to significant toxicity, with many patients
unable to receive this kind of treatment, even in first line setting. There is, therefore, a
great need to provide patients with less toxic agents such as the novel targeted therapies,
with the potential to improve the efficacy and maintain a good quality of life. Bortezomib,
a proteasome inhibitor, has shown benefit as single agent in pretreated patients with
similar or lesser toxicity compared to chemotherapy. The current project is a phase II trial
that will include 46 patients with advanced NSCLC and without prior chemotherapy. An early
tumor assessment (after 6 weeks of therapy) will be performed, combined with regular
clinical and symptom assessment to allow for rapid and appropriate management of
non-responding patients, with cross over to another therapy as per the investigator and
patient choice. The primary objective is efficacy of bortezomib as determined by the rate of
no progression at 6 weeks. Secondary objectives are efficacy of bortezomib as determined by
objective response rate (incidence of CR and PR), disease control rate (CR, PR and
stabilization), duration of disease control, duration of objective response,
progression-free survival,overall survival, safety of bortezomib, rate of doublet therapy in
second line.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of VELCADE as determined by the rate of no progression at 6 weeks
Jean-Charles SORIA, MD, PhD
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
VELCADE
NCT00346645
June 2006
December 2007
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