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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gemcitabine<br> | Drug: Gemcitabine<br>* 1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles<br>|
| Experimental: gemcitabine + cisplatin<br> | Drug: Gemcitabine<br>* 1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles<br>Drug: Cisplatin<br>* 60 mg/m2 day 1 every 3 weeks for 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| worst grade toxicity per patient | worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03 | at end of each 3 week cycle of chemotherapy | 
| progression free survival |  | every 9 weeks | 
| quality of life |  | baseline and 8, 21, 29, and 42 days after therapy initiated | 
| objective response |  | after 9 and 18 weeks of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, chemotherapy