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

Sponsor
National Cancer Institute, Naples (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01405586
Collaborator
(none)
299
Enrollment
49
Locations
2
Arms
128.1
Anticipated Duration (Months)
6.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
299 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Mar 1, 2011
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: gemcitabine

Drug: Gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Experimental: gemcitabine + cisplatin

Drug: Gemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles

Drug: Cisplatin
60 mg/m2 day 1 every 3 weeks for 6 cycles

Outcome Measures

Primary Outcome Measures

  1. overall survival [one year]

Secondary Outcome Measures

  1. worst grade toxicity per patient [at end of each 3 week cycle of chemotherapy]

    worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03

  2. progression free survival [every 9 weeks]

  3. quality of life [baseline and 8, 21, 29, and 42 days after therapy initiated]

  4. objective response [after 9 and 18 weeks of therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Villa Scassi Genova GE Italy 16100
2 Policlinico Giaccone Palermo PA Italy 90127
3 Azienda Ospedaliera Universitaria Senese Siena SI Italy 53100
4 Ospedale Regina Apostolorum Albano Laziale Italy
5 Ospedale San Lazzaro Alba Italy
6 AOU Ospedale Riuniti Umberto I Ancona Italy
7 ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma Aprilia Italy
8 Ospedale Cardinale Massaia Asti Italy
9 S. Giuseppe Moscati Avellino Italy
10 Centro Riferimento Oncologico Aviano Italy
11 Ospedale Senatore Antonio Perrino Brindisi Italy
12 Ospedale A. Cardarelli Campobasso Italy
13 Ospedale Ramazzini di Carpi Carpi Italy
14 Ospedale S. Spirito Casale Monferrato Italy
15 A.O. Garibaldi Nesima Catania Italy
16 Ospedale Mater Domini Catanzaro Italy
17 Ospedale della Madonna della Navicella Chioggia Italy
18 Ospedale Civile di Faenza Faenza Italy
19 A.O.U. Arcispedale Sant'Anna di Ferrara Ferrara Italy
20 Ospedale Don Luigi Di Liegro Gaeta Italy
21 IRCCS San Martino -IST Genova Genova Italy
22 Ospedale F. Veneziale Isernia Italy
23 A.O. Vito Fazzi-Lorusso Lecce Italy
24 Ospedale Civile di Legnano Legnano Italy
25 Istituto Sceintifico Romagnolo Meldola Italy
26 Ospedale L. Sacco Polo Universitario Milano Italy
27 Ospedale San Paolo Milano Italy
28 U.L.S.S. 13 Mirano Italy
29 Ospedale San Gerardo Monza Italy
30 Azienda Ospedaliera Cardarelli Napoli Italy 80131
31 Second University of Naples Napoli Italy 80131
32 A.O. Università Federico II Napoli Italy
33 AORN Ospedale dei Colli - Osp Monaldi Napoli Italy
34 Istituto Nazionale dei Tumori Napoli Italy
35 Istituto Oncologico Veneto Padova Italy
36 Ospedale Andrea Tortora Pagani - Ospedale Civile Umbero I Pagani Italy
37 Casa di Cura La Maddalena Palermo Italy
38 Ospedale Buccheri La Ferla - Fatebenefratelli Palermo Italy
39 Fondazione Salvatore Maugeri Pavia Italy
40 Ospedale Guglielmo d Saliceto-Piacenza Piacenza Italy
41 Azienda Ospedaliera S. Carlo Potenza Italy
42 Ospedale S. Maria delle Croci Ravenna Italy
43 Ospedale Umberto I Ravenna Italy
44 A.O. S. Camillo Forlanini Roma Italy
45 Campus Biomedico Policlinio Universitario Roma Italy
46 Ospedale S. Giovanni Calibita Fatebenefratelli Roma Italy
47 Ospedale S. Andrea Vercelli Italy
48 Ospedale S. Bortolo ULSS 6 Vicenza Italy
49 ASL Viterbo - Ospedale Belcolle Viterbo Italy

Sponsors and Collaborators

  • National Cancer Institute, Naples

Investigators

  • Principal Investigator: Cesare Gridelli, M.D., S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
  • Principal Investigator: Francesco Perrone, M.D., Ph.D, National Cancer Institute Naples, Italy; Director Clinical Trials Unit
  • Principal Investigator: Ciro Gallo, M.D., Ph.D, Second University of Naples, Italy; Chair of Medical Statistics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01405586
Other Study ID Numbers:
  • MILES-3
  • 2009-013540-36
First Posted:
Jul 29, 2011
Last Update Posted:
Mar 4, 2021
Last Verified:
Mar 1, 2021
Keywords provided by National Cancer Institute, Naples
elderly
chemotherapy
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Gemcitabine

Study Results

No Results Posted as of Mar 4, 2021