Overview

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