Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
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- user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).</p>\n', created = 1283569242, expire = 1283655642, headers = '', serialized = 0 WHERE cid = '1:b21b5f1250601adbfe5a65001988938a' in /persistent/html/includes/cache.inc on line 109.
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- user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).</p>\n', created = 1283569242, expire = 1283655642, headers = '', serialized = 0 WHERE cid = '1:3e4455e7e4cd36051b71d8fce7733135' in /persistent/html/includes/cache.inc on line 109.
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- user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-three survival time for these patients.</p>\n', created = 1283569242, expire = 1283655642, headers = '', serialized = 0 WHERE cid = '1:a4233f62dc67d29b9a408bb1a8aac90b' in /persistent/html/includes/cache.inc on line 109.
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- user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)</li>\n<li>No evidence of metastatic disease</li>\n<li>No prior treatment</li>\n<li>Adequate organ function</li>\n<li>Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Metastasis</li>\n<li>Prior treatment</li>\n<li>Malignant pleural or pericardial effusion</li>\n<li>Peripheral neuropathy >= grade 2</li>\n</ul>\n</p>', created = 1283569243, expire = 1283655643, headers = '', serialized = 0 WHERE cid = '1:4d971cb0f1a06f8d1522eb058f8bef7d' in /persistent/html/includes/cache.inc on line 109.
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- user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Assess the serious adverse event profile for erlotinib [ Time Frame: 18 months ] [ Designated as safety issue: No ]</p>\n', created = 1283569243, expire = 1283655643, headers = '', serialized = 0 WHERE cid = '1:13f6ba192e3b39b05acd19c1e6c61f84' in /persistent/html/includes/cache.inc on line 109.
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Trial phase:
Phase III
Recruitment status:
Active, not recruiting This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).
Conditions
Asthma
Brain and Central Nervous System Tumors
Breast Cancer
Cancer
Cardiovascular Diseases
Colorectal Cancer
Depression
Healthy
Heart Diseases
HIV Infections
Hypertension
Leukemia
Lung Cancer
Lymphoma
Myelodysplastic Syndromes
Obesity
Ovarian Cancer
Prostate Cancer
Schizophrenia
Unspecified Adult Solid Tumor, Protocol Specific
Clinical trial sponsors
AstraZeneca
Bristol-Myers Squibb
Department of Veterans Affairs
Eli Lilly and Company
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
GlaxoSmithKline
Hoffmann-La Roche
M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Merck
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Drug Abuse (NIDA)
Novartis
Pfizer
Sanofi-Aventis
User login
Study design
Active Control
Cohort
Crossover Assignment
Dose Comparison
Double-Blind
Double Blind (Subject, Investigator)
Efficacy Study
Non-Randomized
Open Label
Other
Parallel Assignment
Placebo Control
Prevention
Prospective
Randomized
Safety/Efficacy Study
Safety Study
Single Group Assignment
Treatment
Uncontrolled
