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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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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
Actual Primary Completion Date :	November 2016
Estimated Study Completion Date :	September 2018

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	70 Years and older (Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 49 Study Locations

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
Principal Investigator:	Massimo Di Maio, M.D.	National Cancer Institute, Naples

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT01656551 History of Changes
Other Study ID Numbers:	MILES-4; 2012-000164-25 ( EudraCT Number )
First Posted:	August 3, 2012
Last Update Posted:	October 6, 2017
Last Verified:	October 2017

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; Pemetrexed	Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; 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