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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01405586
First received: February 26, 2010
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Stage IIIB
Drug: Gemcitabine
Drug: Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • worst grade toxicity per patient [ Time Frame: at end of each 3 week cycle of chemotherapy ] [ Designated as safety issue: Yes ]
    worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03

  • progression free survival [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline and 8, 21, 29, and 42 days after therapy initiated ] [ Designated as safety issue: No ]
  • objective response [ Time Frame: after 9 and 18 weeks of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405586

Contacts
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Massimo Di Maio, M.D. +39 081 5903383 massimo.dimaio@usc-intnapoli.net

Locations
Italy
Ospedale Villa Scassi Recruiting
Genova, GE, Italy, 16100
Policlinico Giaccone Recruiting
Palermo, PA, Italy, 90127
Azienda Ospedaliera Universitaria Senese Recruiting
Siena, SI, Italy, 53100
Ospedale San Lazzaro Recruiting
Alba, Italy
Ospedale Regina Apostolorum Recruiting
Albano Laziale, Italy
S. Giuseppe Moscati Recruiting
Avellino, Italy
Ospedale Senatore Antonio Perrino Recruiting
Brindisi, Italy
Ospedale A. Cardarelli Recruiting
Campobasso, Italy
Ospedale Ramazzini di Carpi Recruiting
Carpi, Italy
Ospedale Civile di Faenza Recruiting
Faenza, Italy
A.O. Vito Fazzi-Lorusso Recruiting
Lecce, Italy
Istituto Sceintifico Romagnolo Recruiting
Meldola, Italy
Ospedale L. Sacco Polo Universitario Recruiting
Milano, Italy
U.L.S.S. 13 Recruiting
Mirano, Italy
Ospedale San Gerardo Recruiting
Monza, Italy
Istituto Nazionale dei Tumori Recruiting
Napoli, Italy
Second University of Naples Recruiting
Napoli, Italy, 80131
A.O. Università Federico II Recruiting
Napoli, Italy
Azienda Ospedaliera Cardarelli Recruiting
Napoli, Italy, 80131
Istituto Oncologico Veneto Recruiting
Padova, Italy
Ospedale Guglielmo d Saliceto-Piacenza Recruiting
Piacenza, Italy
Azienda Ospedaliera S. Carlo Recruiting
Potenza, Italy
Ospedale Umberto I Recruiting
Ravenna, Italy
Ospedale S. Maria delle Croci Recruiting
Ravenna, Italy
A.O. S. Camillo Forlanini Recruiting
Roma, Italy
IRCCS Casa Sollievo Sofferenza Recruiting
S. Giovanni Rotondo, 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
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01405586     History of Changes
Other Study ID Numbers: MILES-3, 2009-013540-36
Study First Received: February 26, 2010
Last Updated: September 23, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
elderly
chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014