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Sponsors and Collaborators: |
Stanford University Eli Lilly and Company Genentech |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00323869 |
This is a phase II, open label, single arm, multi-institutional trial with a primary endpoint of improvement in progression-free survival (PFS) in newly diagnosed advanced non-small cell lung cancer (NSCLC) (excluding squamous cell carcinoma). All patients will be treated with bevacizumab (15 mg/kg every 3 weeks) in combination with gemcitabine (1000 mg/m2 on day 1 and 8 every 3 weeks) and carboplatin (AUC of 5 every 3 weeks). Patients will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab will continue as long as patients have no evidence of progressive disease and no significant treatment related toxicities.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: bevacizumab Drug: gemcitabine Procedure: chemotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Bevacizumab in Combination With Gemcitabine and Carboplatin in Patients With Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell Carcinoma) |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Advanced stage NSCLC (IIIB with malignant pleural effusion or stage IV) excluding squamous cell histology, with measurable or evaluable disease.
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:- Prior systemic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed at least 6 months prior to study entry.
Significant co-morbidities including:
Contact: Julia Dugay | (650) 725-6413 | jdugay@stanford.edu |
United States, California | |
Santa Clara Valley Medical Center | Recruiting |
San Jose, California, United States | |
Contact: Natalia Kouzminova 408-793-1980 Natalia.Kouzminova@hhs.co.santa-clara.ca.us | |
Principal Investigator: Gary Zhoa | |
VA Palo Alto Healthcare System | Recruiting |
Palo Alto, California, United States | |
Contact: Julia Dugay 650-725-6413 jdugay@stanford.edu | |
Principal Investigator: Kristen Ganjoo | |
Stanford University School of Medicine | Active, not recruiting |
Stanford, California, United States, 94305 |
Principal Investigator: | Gary Zhoa | Santa Clara Valley Health & Hospital System |
Principal Investigator: | Heather A. Wakelee | Stanford University |
Principal Investigator: | Kristen Ganjoo | VA Palo Alto Healthcare System |
Responsible Party: | Stanford University School of Medicine ( Heather A. Wakelee, Principal Investigator ) |
Study ID Numbers: | LUN0013, 96655, AVF3576s, LUN0013, NCT00323869 |
Study First Received: | May 8, 2006 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00323869 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Antimetabolites Thoracic Neoplasms Immunologic Factors Carboplatin Bevacizumab Squamous Cell Carcinoma Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Carcinoma |
Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases Epidermoid Carcinoma Non-small Cell Lung Cancer Carcinoma, Squamous Cell Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Carboplatin Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung |