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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) |
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:
Significant co-morbidities including:
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 | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Melanie San Pedro-Salcedo 650-724-1388 msanpedr@stanford.edu | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Principal Investigator: Heather A. Wakelee | |
Sub-Investigator: Kristen N. Ganjoo | |
Sub-Investigator: Charlotte D Jacobs | |
Sub-Investigator: Branimir I Sikic | |
Sub-Investigator: Kent Mark-Josef Adler |
Principal Investigator: | Heather A. Wakelee | Stanford University |
Study ID Numbers: | LUN0013, 96655, AVF3576s, LUN0013, NCT00323869 |
Study First Received: | May 8, 2006 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00323869 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Thoracic Neoplasms Non-small cell lung cancer Squamous cell carcinoma Carboplatin Bevacizumab Carcinoma Epidermoid carcinoma Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, squamous cell Carcinoma, Squamous Cell Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |