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

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Cisplatin; Gemcitabine

Criteria

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