MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer (MILES-4)
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| ClinicalTrials.gov Identifier: NCT01656551 |
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Recruitment Status :
Active, not recruiting
First Posted : August 3, 2012
Last Update Posted : October 6, 2017
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Sponsor:
National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
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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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: A: Gemcitabine
Single agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks
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Drug: Gemcitabine |
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Experimental: B: Gemcitabine + Cisplatin
Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks
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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 :
- 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 :
- 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
- progression free survival [ Time Frame: 6 months ]
- changes in quality of life [ Time Frame: baseline and up to 18 weeks ]
- objective response [ Time Frame: after 9 and 18 weeks of therapy ]
Other Outcome Measures:
- identification of patient and lesion specific prognostic factors [ Time Frame: 2 years ]
- identification of patient and lesion specific factors predictive of chemotherapy efficacy [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| 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
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 ClinicalTrials.gov identifier (NCT number): NCT01656551
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 |
| 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 Key Record Dates |
| Last Update Posted: | October 6, 2017 |
| Last Verified: | October 2017 |
Keywords provided by National Cancer Institute, Naples:
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elderly chemotherapy |
Additional relevant MeSH terms:
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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 |