A Randomized Phase II Chemoprevention Study of Iloprost Versus Placebo in Patients at High Risk for Lung Cancer
iloprost
+ placebo
Néoplasmes pulmonaires+5
+ Maladies pulmonaires
+ Néoplasmes par site
Étude de prévention
Résumé
Date de début de l'étude : 1 novembre 2001
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Compare the reversal of premalignant histological changes in the bronchial epithelium of patients at high risk for lung cancer (defined by > 20 pack years of smoking and sputum atypia) treated with iloprost vs placebo. * Determine whether this drug modulates Ki-67 proliferation index (Antigen Ki-67) in these patients. * Determine whether this drug affects prostaglandin metabolism in these patients. * Determine the toxicity profile of this drug in these patients. Secondary * Determine whether this drug modulates a panel of biomarkers, including MCM-2(Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in EGFR expression or activity can result in cancer.) , HER2/neu (Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family), RARβ (Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily), p53, FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor), apoptotic index, and microvessel density, in these patients. * Determine the genes whose expression is altered by this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to smoking status (current vs former) and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral iloprost twice daily. * Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity. Patients are followed at 1 month and then annually thereafter. PROJECTED ACCRUAL: A total of 152 patients (76 \[38 current smokers and 38 former smokers\] per treatment arm) will be accrued for this study within 2 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.152 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 85 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Current or former smoker with ≥ 20 pack-year history of smoking with no tobacco use within the past 6 months * Mild atypia or worse on sputum cytology, or * Bronchial biopsy with mild or worse dysplasia within the past 12 months * Age 18 and over * SWOG (Southwest Oncology Group)0-2 * Life expectancy at least 6 months * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) * Transaminases ≤ 2.5 times ULN * Bilirubin ≤ 2.0 mg/dL * Albumin ≥ 2.5 g/dL * Creatinine ≤ 1.5 mg/dL * Well-controlled atrial fibrillation OR rare (\< 2 minutes) premature ventricular contractions allowed * Negative pregnancy test * Fertile patients must use effective contraception * Able and willing to undergo bronchoscopy Exclusion Criteria * Clinically apparent bleeding diathesis * Ventricular tachycardia * Multifocal premature ventricular contractions or supraventricular tachycardias with rapid ventricular response * Pneumonia or acute bronchitis within the past 2 weeks * Hypoxemia (\< 90% saturation with supplemental oxygen) * Pregnant or nursing * Malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Serious medical condition that would preclude bronchoscopy or study participation * Clinically active coronary artery disease * Myocardial infarction within the past 6 weeks * Chest pain * Congestive heart failure * Cardiac dysrhythmia that is potentially life-threatening Exclusion for PRIOR CONCURRENT THERAPY: * Biologic therapy (Not specified) * More than 5 years since prior chemotherapy * More than 6 weeks since prior inhaled steroids * More than 5 years since prior thoracic radiotherapy * Surgery (Not specified) * No prior prostacyclin
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
ExpérimentalGroupe II
PlaceboObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 6 sites
Veterans Affairs Medical Center - Denver
Denver, United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United StatesMayo Clinic Cancer Center
Rochester, United States