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

National Cancer Institute, Naples

Status and phase

Active, not recruiting

Phase 3

Conditions

Non-small Cell Lung Cancer Stage IIIB

Non-small Cell Lung Cancer Metastatic

Treatments

Drug: Gemcitabine

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01405586

2009-013540-36 (EudraCT Number)

MILES-3

Details and patient eligibility

About

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.

Enrollment

299 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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