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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Genentech Eli Lilly and Company |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00351039 |
This is a Phase I/II trial of elderly patients (> 70 years of age) with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Therapy consists of three drugs (Alimta, Bevacizumab and Tarceva) given every 28 days. Alimta * Bevacizumab are given days 1 & 15 and Tarceva are given for 7 days starting on days 2 and 15.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Bevacizumab Drug: Erlotinib Drug: Pemetrexed |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced (Stage IIIB(With Malignant Pleural Effusion) or IV) Non-Squamous Non-Small Cell Lung Cancer (NSCLC). |
Enrollment: | 9 |
Study Start Date: | July 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Single arm phase II trial in elderly patients with advanced stage Non-Squamous Non-Small Cell Lung Cancer
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Drug: Bevacizumab Drug: Erlotinib Drug: Pemetrexed |
This is a Phase I/II trial of elderly patients (> 70 years of age) with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled.
Treatment Regimen:
Alimta 500mg/m2 I.V. Day 1 and Day 15 Bevacizumab 10mg/Kg I. V. Day 1 and Day 15 Tarceva 150mg PO QD for 7 days starting day 2 and day 15 Repeat cycles every 28 days.
All three drugs will be continued for two cycles after maximal response. After which patient will be maintained only on the Bevacizumab and Tarceva until progression. If patient has stable disease after the first two cycles then patient will be given another two cycles with all three drugs before maintenance treatment withBevacizumab and Tarceva is initiated.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | George Simon, MD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute ( George Simon, M.D. ) |
Study ID Numbers: | MCC-14659 |
Study First Received: | July 11, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00351039 |
Health Authority: | United States: Food and Drug Administration |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Pleural Diseases Pleural Effusion, Malignant Bevacizumab Carcinoma Folic Acid |
Pemetrexed Pleural Effusion Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Pleural Neoplasms |
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 Protein Kinase Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |