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MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer (MILES-4)

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: NCT01656551
Recruitment Status : Active, not recruiting
First Posted : August 3, 2012
Last Update Posted : March 4, 2021
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief Summary:
The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Stage IIIB Drug: Gemcitabine Drug: Pemetrexed Drug: Cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Factorial Study Comparing Pemetrexed With Gemcitabine and Testing the Efficacy of the Addition of Cisplatin in Elderly Patients With Non Squamous Advanced, Metastatic or Recurrent NSCLC.
Actual Study Start Date : August 2012
Estimated Primary Completion Date : November 22, 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: A: Gemcitabine
Single agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks
Drug: Gemcitabine
Experimental: B: Gemcitabine + Cisplatin
Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks
Drug: Gemcitabine
Drug: Cisplatin
60 mg/m2 day 1 every 3 weeks

Active Comparator: C: Pemetrexed Drug: Pemetrexed
500 mg/m2 day 1 every 3 weeks

Experimental: D: Pemetrexed + Cisplatin Drug: Pemetrexed
500 mg/m2 day 1 every 3 weeks

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

Primary Outcome Measures :
  1. overall survival [ Time Frame: one year ]
    factorial design with two comparisons: single agent chemotherapy versus chemotherapy plus cisplatin (Arms A+C versus Arms B + D), and gemcitabine versus pemetrexed (Arms A+B versus Arms C+D)

Secondary Outcome Measures :
  1. worst grade toxicity per patient [ Time Frame: evaluated at end of each 3 week cycle of chemotherapy up to 18 weeks ]
    according to Common Toxicity Criteria for Adverse Events v. 4.03

  2. progression free survival [ Time Frame: 6 months ]
  3. changes in quality of life [ Time Frame: baseline and up to 18 weeks ]
  4. objective response [ Time Frame: after 9 and 18 weeks of therapy ]

Other Outcome Measures:
  1. identification of patient and lesion specific prognostic factors [ Time Frame: 2 years ]
  2. identification of patient and lesion specific factors predictive of chemotherapy efficacy [ Time Frame: 2 years ]

Information from the National Library of Medicine

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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:

  • Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
  • Non squamous tumor type (including those with a non-specified tumor type).
  • Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
  • Both patients at first diagnosis or those with disease recurrence after former surgery are eligible.
  • At least one target or non-target lesion according to RECIST revised version 1.1.
  • Male or female > or = 70 years of age.
  • ECOG PS 0 or 1.
  • Life expectancy > 3 months.
  • Neutrophils > or = 1500 mm3, platelets > or = 100000 mm3, and haemoglobin > or = 9 g/dL.
  • Bilirubin level either normal or < 1.5 x ULN.
  • AST (SGOT) and ALT (SGPT) < or = 2.5 x ULN (< or = 5 x ULN if liver metastasis are present).
  • Serum creatinine < 1.5 x ULN.
  • Signed written informed consent.

Exclusion Criteria:

  • Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy.
  • Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications.
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
  • Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed).
  • Known or suspected hypersensitivity to any of the study drugs

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): NCT01656551

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Sponsors and Collaborators
National Cancer Institute, Naples
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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
Principal Investigator: Massimo Di Maio, M.D. National Cancer Institute, Naples
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute, Naples Identifier: NCT01656551    
Other Study ID Numbers: MILES-4
2012-000164-25 ( EudraCT Number )
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Keywords provided by National Cancer Institute, Naples:
Additional relevant MeSH terms:
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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
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors