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Sponsors and Collaborators: |
Pharmatech Genentech Sanofi-Aventis |
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Information provided by: | Pharmatech |
ClinicalTrials.gov Identifier: | NCT00766246 |
This is a randomized, open-label, multicenter study in 160 patients in first line treatment and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).
Condition | Intervention | Phase |
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Stage IIIB or IV Non-Small Cell Lung Cancer |
Drug: bevacizumab Drug: pemetrexed Drug: docetaxel Drug: carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second-Line Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer |
Estimated Enrollment: | 160 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | August 2013 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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First-line: Experimental
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Drug: bevacizumab
15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line, maintenance, and second-line treatments
Drug: docetaxel
75 mg/m2 administered in 21-day cycles on day 1 of each cycle for first line treatment
Drug: carboplatin
AUC=6 administered in 21-day cycles on day 1 of each cycle for first-line treatment
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Maintenance: Experimental
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Drug: bevacizumab
15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line, maintenance, and second-line treatments
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Second-Line Arm A: Active Comparator
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Drug: bevacizumab
15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line, maintenance, and second-line treatments
Drug: pemetrexed
500 mg/m2 administered in 21-day cycles on day 1 of each cycle for second-line treatment
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Second-Line Arm B: Active Comparator
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Drug: pemetrexed
500 mg/m2 administered in 21-day cycles on day 1 of each cycle for second-line treatment
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This phase II clinical trial will address the issues of bevacizumab treatment duration and treatment safety as first-line therapy for patients with non-squamous NSCLC. Following disease progression or treatment failure, the potential benefit of continued bevacizumab therapy will be tested by randomizing patients to two treatment arms, including second-line chemotherapy with or without further bevacizumab. It is hypothesized that continuation of bevacizumab with pemetrexed as second-line treatment following progression will result in improved clinical outcomes for patients with NSCLC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function:
Exclusion Criteria:
History of serious systemic disease including:
Contact: Joel Aronoff | 720-917-7452 | joela@pharmatech.com |
Contact: Nikos Sophos | 720-917-7470 | nickolass@pharmatech.com |
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center Penn State College of Medicine Penn State Hershey Cancer Institute, H072 | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Chandra P Belani, MD 717-531-1078 | |
Contact: Cindy Naret 717-531-5232 | |
Principal Investigator: Chandra P. Belani, MD |
Principal Investigator: | Chandra P Belani, MD | Penn State Milton S. Hershey Medical Center, Penn State College of Medicine, Penn State Hershey Cancer Institute |
Responsible Party: | Penn State Hershey Cancer Institute ( Chandra P. Belani, M.D./Principal Investigator ) |
Study ID Numbers: | PSHCI 08-009 |
Study First Received: | October 1, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00766246 |
Health Authority: | United States: Institutional Review Board |
Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer Lung Cancer |
Thoracic Neoplasms Non-small cell lung cancer Bevacizumab Carboplatin Carcinoma Docetaxel Pemetrexed |
Folic Acid Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |