Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB
Conditions
Keywords
elderly, chemotherapy
Brief 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.
Interventions
DRUGGemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
DRUGCisplatin
60 mg/m2 day 1 every 3 weeks for 6 cycles
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| worst grade toxicity per patient | at end of each 3 week cycle of chemotherapy | worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03 |
| 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 | — |
Countries
Italy
Outcome results
None listed