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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405586
Recruitment Status : Active, not recruiting
First Posted : July 29, 2011
Last Update Posted : October 6, 2017
Information provided by (Responsible Party):
National Cancer Institute, Naples

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

Study Type : Interventional  (Clinical Trial)
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.
Study Start Date : March 2011
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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

Primary Outcome Measures :
  1. overall survival [ Time Frame: one year ]

Secondary Outcome Measures :
  1. worst grade toxicity per patient [ Time Frame: 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 [ Time Frame: every 9 weeks ]
  3. quality of life [ Time Frame: baseline and 8, 21, 29, and 42 days after therapy initiated ]
  4. objective response [ Time Frame: after 9 and 18 weeks of therapy ]

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Ages Eligible for Study:   70 Years and older   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405586

  Show 50 Study Locations
Sponsors and Collaborators
National Cancer Institute, Naples
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

Responsible Party: National Cancer Institute, Naples Identifier: NCT01405586     History of Changes
Other Study ID Numbers: MILES-3
2009-013540-36 ( EudraCT Number )
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by National Cancer Institute, Naples:

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