Vinorelbine Versus Gemcitabine Versus Gemcitabine and Vinorelbine in Elderly Patients With Stage IIIB-IV Non-Small Cell Lung Cancer
gemcitabine hydrochloride
+ vinorelbine tartrate
Néoplasmes bronchiques+7
+ Carcinome bronchogénique
+ Maladies pulmonaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the activity and toxicities of gemcitabine in elderly patients with non-small cell lung cancer. II. Determine the activity and toxicity of the combination of gemcitabine and vinorelbine in these patients. III. Compare the survival rate and quality of life of these patients treated with combination chemotherapy versus single agent chemotherapy. IV. Compare objective response and time to progression of these patients treated with these chemotherapy regimens. V. Compare the toxicities of these three regimens in these patients. VI. Compare the number of hospitalizations, palliative radiation therapies, antibiotic therapies, corticosteroid therapies, analgesic therapies, and hematopoietic growth factor therapies needed for these patients treated with these chemotherapy regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage of disease (IIIB vs IV), and performance status (0 vs 1 vs 2). Patients are randomized to one of three treatment arms. Patients receive either vinorelbine IV, gemcitabine IV, or both on days 1 and 8 of each 21 day course. Patients who achieve an objective response or stable disease after 3 courses receive 3 more courses (for a total of 6 courses). Quality of life is assessed before treatment, after course 4 (or 3 weeks after course 3, if therapy is stopped), and at 21 days after course 6 (or 12 weeks after course 3). PROJECTED ACCRUAL: A total of 630 patients (210 patients per arm) 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.630 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.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 70 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 or cytologically proven non-small cell lung cancer Stage IV OR Stage IIIB that has supraclavicular lymph node metastases or has pleural deposits and is not curable with surgery or radical radiotherapy No brain metastases suspected clinically or demonstrated radiologically PATIENT CHARACTERISTICS: Age: 70 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: (Unless caused by tumor) Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater than 1.25 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: No other serious medical illness No prior or concurrent malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: No prior chemotherapy
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
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, ItalyOuvrir Istituto Nazionale per lo Studio e la Cura dei Tumori dans Google Maps