MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer

Non-small Cell Lung Cancer Metastatic Clinical Trial

— MILES-3  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01405586
• Other study ID #: MILES-3
• Secondary ID: 2009-013540-36
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2011
• Est. completion date: November 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 299
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic
• Non-small Cell Lung Cancer Stage IIIB

Intervention

Drug:
• Gemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
• Gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
• Cisplatin
60 mg/m2 day 1 every 3 weeks for 6 cycles

Locations

Country	Name	City	State
Italy	Ospedale San Lazzaro	Alba
Italy	Ospedale Regina Apostolorum	Albano Laziale
Italy	AOU Ospedale Riuniti Umberto I	Ancona
Italy	ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma	Aprilia
Italy	Ospedale Cardinale Massaia	Asti
Italy	S. Giuseppe Moscati	Avellino
Italy	Centro Riferimento Oncologico	Aviano
Italy	Ospedale Senatore Antonio Perrino	Brindisi
Italy	Ospedale A. Cardarelli	Campobasso
Italy	Ospedale Ramazzini di Carpi	Carpi
Italy	Ospedale S. Spirito	Casale Monferrato
Italy	A.O. Garibaldi Nesima	Catania
Italy	Ospedale Mater Domini	Catanzaro
Italy	Ospedale della Madonna della Navicella	Chioggia
Italy	Ospedale Civile di Faenza	Faenza
Italy	A.O.U. Arcispedale Sant'Anna di Ferrara	Ferrara
Italy	Ospedale Don Luigi Di Liegro	Gaeta
Italy	IRCCS San Martino -IST Genova	Genova
Italy	Ospedale Villa Scassi	Genova	GE
Italy	Ospedale F. Veneziale	Isernia
Italy	A.O. Vito Fazzi-Lorusso	Lecce
Italy	Ospedale Civile di Legnano	Legnano
Italy	Istituto Sceintifico Romagnolo	Meldola
Italy	Ospedale L. Sacco Polo Universitario	Milano
Italy	Ospedale San Paolo	Milano
Italy	U.L.S.S. 13	Mirano
Italy	Ospedale San Gerardo	Monza
Italy	A.O. Università Federico II	Napoli
Italy	AORN Ospedale dei Colli - Osp Monaldi	Napoli
Italy	Azienda Ospedaliera Cardarelli	Napoli
Italy	Istituto Nazionale dei Tumori	Napoli
Italy	Second University of Naples	Napoli
Italy	Istituto Oncologico Veneto	Padova
Italy	Ospedale Andrea Tortora Pagani - Ospedale Civile Umbero I	Pagani
Italy	Casa di Cura La Maddalena	Palermo
Italy	Ospedale Buccheri La Ferla - Fatebenefratelli	Palermo
Italy	Policlinico Giaccone	Palermo	PA
Italy	Fondazione Salvatore Maugeri	Pavia
Italy	Ospedale Guglielmo d Saliceto-Piacenza	Piacenza
Italy	Azienda Ospedaliera S. Carlo	Potenza
Italy	Ospedale S. Maria delle Croci	Ravenna
Italy	Ospedale Umberto I	Ravenna
Italy	A.O. S. Camillo Forlanini	Roma
Italy	Campus Biomedico Policlinio Universitario	Roma
Italy	Ospedale S. Giovanni Calibita Fatebenefratelli	Roma
Italy	Azienda Ospedaliera Universitaria Senese	Siena	SI
Italy	Ospedale S. Andrea	Vercelli
Italy	Ospedale S. Bortolo ULSS 6	Vicenza
Italy	ASL Viterbo - Ospedale Belcolle	Viterbo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		one year
Secondary	worst grade toxicity per patient	worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03	at end of each 3 week cycle of chemotherapy
Secondary	progression free survival		every 9 weeks
Secondary	quality of life		baseline and 8, 21, 29, and 42 days after therapy initiated
Secondary	objective response		after 9 and 18 weeks of therapy