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Sponsored by: |
Institut Gustave Roussy |
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Information provided by: | Institut Gustave Roussy |
ClinicalTrials.gov Identifier: | NCT00346645 |
The purpose of this study is to determine whether Bortezomib is effective in the treatment of patients with non-small-cell lung cancer who have not received any prior chemotherapy regimen for advanced disease.
Condition | Intervention | Phase |
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Stage IIIB or IV Non-Small Cell Lung Cancer |
Drug: Bortezomid (VELCADE®) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 46 |
Study Start Date: | June 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | VELCADE, CSET 1192 |
Study First Received: | June 29, 2006 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00346645 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
NON-SMALL CELL LUNG CANCER METASTATIC |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Bortezomib Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |