Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
doxorubicin hydrochloride
Adénocarcinome du poumon+18
+ Adénocarcinome
+ Néoplasmes bronchiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin administered every 3 weeks in patients with primary lung cancer or cancer metastatic to the lung. Determine the toxic effects and pharmacokinetic profile of this regimen in this patient population. Examine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients. Obtain preliminary evidence of therapeutic activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive inhaled doxorubicin every 3 weeks. Treatment continues for a maximum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients may reenter at a higher dose level after a 3-month waiting period. Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 6 weeks. PROJECTED ACCRUAL: A total of 3-36 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 18 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 primary lung cancer or cancer metastatic to the lung that is not potentially curable by standard chemotherapy, radiotherapy, or surgery Bronchoalveolar cell lung cancer allowed Lung metastases from soft tissue sarcoma allowed No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 160,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.0 mg/dL AST/ALT less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: LVEF normal by MUGA scan or echocardiography No unstable angina No congestive heart failure No symptomatic arrhythmias Pulmonary: DLCO at least 65% of normal FVC at least 50% predicted FEV1 at least 50% predicted Resting oxygen saturation at least 90% Exercise oxygen saturation at least 85% No complete atelectasis No asthma Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No congenital problems (e.g., cleft palate) or other anomalies that would prevent tight fit of mouth seal No other concurrent illness that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior bleomycin or nitrosoureas No prior mitomycin greater than 25 mg/m^2 No prior anthracyclines greater than 450 mg/m^2 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior chest (pulmonary or mediastinal) or thoracic spine radiotherapy Patients with only chest wall or primary breast radiation are eligible No concurrent thoracic irradiation Surgery: See Disease Characteristics No prior pneumonectomy Other: No daily or as necessary respiratory drugs via inhaler or nebulizer No other concurrent experimental drugs
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 2 sites
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google MapsArthur G. James Cancer Hospital - Ohio State University
Columbus, United States