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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 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: February 20, 2014
Last verified: February 2014

February 26, 2010
February 20, 2014
March 2011
September 2015   (final data collection date for primary outcome measure)
overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01405586 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIB
  • Drug: Gemcitabine
    1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
  • Drug: Gemcitabine
    1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
  • Drug: Cisplatin
    60 mg/m2 day 1 every 3 weeks for 6 cycles
  • Active Comparator: gemcitabine
    Intervention: Drug: Gemcitabine
  • Experimental: gemcitabine + cisplatin
    Interventions:
    • Drug: Gemcitabine
    • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
December 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
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
Italy
 
NCT01405586
MILES-3, 2009-013540-36
No
National Cancer Institute, Naples
National Cancer Institute, Naples
Not Provided
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
National Cancer Institute, Naples
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP