G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients

Four treatment arms are planned.

• GEMVIN: gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 & 8, every 21 days
• GEMCAR: gemcitabine 1000 on days 1 & 8 and carboplatin AUC 3.5 or 4 or 4.5 on day 1, every 21 days
• GEMCIS: gemcitabine 1000 mg/m2 on days 1 & 8 and cisplatin 50 or 60 or 70 mg/m2 on day 1, every 21 days
• GEMETO: gemcitabine 1000 mg/m2 on days 1 & 8 and etoposide 60 or 70 or 80 mg/m2 on days 1,2,3 every 21 days

For the study of the GEMVIN combination a two-stage minimax flexible design will be applied. For the remaining 3 combinations (GEMCAR, GEMCIS, GEMETO) a phase 1/2 design aimed at looking for optimal dose within a Bayesian framework will be applied.

Inclusion criteria

• Histologic or cytologic diagnosis of SCLC
• Extensive disease
• Measurable disease
• Performance Status (ECOG) < o = 2
• Age > o = 70 years.
• Written informed consent.

Exclusion criteria

• Previous chemotherapy.
• Previous or concomitant malignancies (with the exception of adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix)
• •Neutrophils<2.000/mm3;platelets<100.000/mm3; hemoglobin < 10 g/dl
• Creatinine > 1.5 time the upper limit
• AST, ALT > 2.5 times and/or bilirubin > 1.5 time the upper limit of normal if liver metastases are absent or AST, ALT ³5 times and bilirubin > 3 times the upper limit of normal if liver metastases are present
• Symptomatic brain metastases