A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer
Collecte de données
Néoplasmes bronchiques+7
+ Carcinome du poumon non à petites cellules
+ Carcinome bronchogénique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 2003
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer. * Determine the toxicity profile of this regimen in these patients. Secondary * Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients. * Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen. OUTLINE: This is a nonrandomized, dose-escalation study of celecoxib. Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment beyond 2 courses at the investigator's discretion. Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The BAD is defined as the maximum decrease in the level of PGE\_2 where no DLT occurs. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 21-27 patients will be accrued for this study.
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.Traitement
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.À partir de 21 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
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB or IV * Measurable disease * Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy * No active CNS metastases PATIENT CHARACTERISTICS: Age * 21 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2.5 times upper limit of normal (ULN) * PT and/or PTT no greater than 1.5 times ULN Renal * Creatinine no greater than 2 mg/dL Cardiovascular * No New York Heart Association class III or IV cardiac disease * No myocardial infarction within the past year * No symptomatic ventricular arrhythmia * No symptomatic conduction abnormality Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior gastrointestinal ulceration, bleeding, or perforation * No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study * No concurrent disease or medical condition that would preclude study treatment or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior corticosteroids * No concurrent steroids (including chronic use) * Concurrent topical steroids allowed Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 4 weeks since prior non-cytotoxic investigational agents * More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs) * No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC * No prior epidermal growth factor receptor inhibitor for metastatic NSCLC * No concurrent COX-2 inhibitors * No concurrent NSAIDs * No concurrent fluconazole or lithium
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 1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, United StatesOuvrir Jonsson Comprehensive Cancer Center at UCLA dans Google Maps