Clinical trial NCT01405586: MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
Official title: Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Stage IIIB
Keywords: elderly
chemotherapy
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 299
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.


Eligibility criteria: Inclusion Criteria:

* Cytological or histological diagnosis of non small-cell lung cancer (NSCLC)
* Stage III B or Stage IV disease
* Age \> or = 70 years
* ECOG Performance status 0 or 1
* Patient at first diagnosis or with recurrence after primary surgery
* At least one target or non-target lesion according to RECIST criteria
* Life expectancy of at least 3 months
* Neutrophils \> 1500/mm3, platelets \> 100,000/mm3, hemoglobin \> 10g/dl
* Creatinine \< 1.5 x the upper normal limit
* AST and ALT \< 2.5 x the upper normal limits (\< 5 x the upper normal limit in the presence of hepatic metastasis)
* Bilirubin \< 1.5 x the upper normal limit
* Signed informed consent

Exclusion Criteria:

* Previous chemotherapy for advanced disease
* History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
* Symptomatic cerebral or spinal cord metastasis
* Myocardial infarct within the last 12 months
* Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy.
* Known or suspected hypersensitivity to any of the drugs used in the study
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent

Primary outcomes:
measure: overall survival
timeFrame: one year
Secondary outcomes:
measure: worst grade toxicity per patient
timeFrame: at end of each 3 week cycle of chemotherapy
measure: progression free survival
timeFrame: every 9 weeks
measure: quality of life
timeFrame: baseline and 8, 21, 29, and 42 days after therapy initiated
measure: objective response
timeFrame: after 9 and 18 weeks of therapy
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale Villa Scassi
state: GE
city: Palermo
country: Italy
facility: Policlinico Giaccone
state: PA
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
state: SI
city: Albano Laziale
country: Italy
facility: Ospedale Regina Apostolorum
city: Alba
country: Italy
facility: Ospedale San Lazzaro
city: Ancona
country: Italy
facility: AOU Ospedale Riuniti Umberto I
city: Aprilia
country: Italy
facility: ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma
city: Asti
country: Italy
facility: Ospedale Cardinale Massaia
city: Avellino
country: Italy
facility: S. Giuseppe Moscati
city: Aviano
country: Italy
facility: Centro Riferimento Oncologico
city: Brindisi
country: Italy
facility: Ospedale Senatore Antonio Perrino
city: Campobasso
country: Italy
facility: Ospedale A. Cardarelli
city: Carpi
country: Italy
facility: Ospedale Ramazzini di Carpi
city: Casale Monferrato
country: Italy
facility: Ospedale S. Spirito
city: Catania
country: Italy
facility: A.O. Garibaldi Nesima
city: Catanzaro
country: Italy
facility: Ospedale Mater Domini
city: Chioggia
country: Italy
facility: Ospedale della Madonna della Navicella
city: Faenza
country: Italy
facility: Ospedale Civile di Faenza
city: Ferrara
country: Italy
facility: A.O.U. Arcispedale Sant'Anna di Ferrara
city: Gaeta
country: Italy
facility: Ospedale Don Luigi Di Liegro
city: Genova
country: Italy
facility: IRCCS San Martino -IST Genova
city: Isernia
country: Italy
facility: Ospedale F. Veneziale
city: Lecce
country: Italy
facility: A.O. Vito Fazzi-Lorusso
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano
city: Meldola
country: Italy
facility: Istituto Sceintifico Romagnolo
city: Milano
country: Italy
facility: Ospedale L. Sacco Polo Universitario
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Mirano
country: Italy
facility: U.L.S.S. 13
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Napoli
country: Italy
facility: Azienda Ospedaliera Cardarelli
city: Napoli
country: Italy
facility: Second University of Naples
city: Napoli
country: Italy
facility: A.O. Università Federico II
city: Napoli
country: Italy
facility: AORN Ospedale dei Colli - Osp Monaldi
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pagani
country: Italy
facility: Ospedale Andrea Tortora Pagani - Ospedale Civile Umbero I
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena
city: Palermo
country: Italy
facility: Ospedale Buccheri La Ferla - Fatebenefratelli
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
city: Piacenza
country: Italy
facility: Ospedale Guglielmo d Saliceto-Piacenza
city: Potenza
country: Italy
facility: Azienda Ospedaliera S. Carlo
city: Ravenna
country: Italy
facility: Ospedale S. Maria delle Croci
city: Ravenna
country: Italy
facility: Ospedale Umberto I
city: Roma
country: Italy
facility: A.O. S. Camillo Forlanini
city: Roma
country: Italy
facility: Campus Biomedico Policlinio Universitario
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli
city: Vercelli
country: Italy
facility: Ospedale S. Andrea
city: Vicenza
country: Italy
facility: Ospedale S. Bortolo ULSS 6
city: Viterbo
country: Italy
facility: ASL Viterbo - Ospedale Belcolle
Study officials:
affiliation: S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
name: Cesare Gridelli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute Naples, Italy; Director Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Second University of Naples, Italy; Chair of Medical Statistics
name: Ciro Gallo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: