Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide

Inclusion Criteria

• •Pathological diagnosis: Histologically or cytologically proven SCLC.
• •Disease stage: extensive stage
• •Measurable disease by the RECIST criteria is required. Lesions that are present in previously irradiated area are non-measurable unless they have appeared or progressed since completion of the radiation.
• •Radiotherapy, if applicable, must have been completed at least 4 weeks before treatment under this protocol and the subject must have recovered from any acute toxicities of radiation.
• •Recovered from any surgical procedure(s).
• •Calculated creatinine clearance \> 55 ml/min using the Cockcroft-Gault formula: Cr Cl in ml/min = (140-age) X (weight in kg) X (1.0 for men or 0.85 for women) / (72 X serum Cr in mg/dl).
• •Total bilirubin \< two times the upper limit of the normal range at the institution and SGOT/AST \< two times the upper limit of normal unless liver metastases are present.
• •ANC \> 1.5 x 109/L and platelet count \> 100 x 109/L.
• •Age \>18 years.
• •Karnofsky Performance Status \> 70% .
• •Infertile subjects or fertile subjects who use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment. Women of childbearing potential must have documentation of a negative, serum HCG pregnancy test. Subjects must be made aware, before entering this trial, of the risk in becoming pregnant or in fathering children.
• •Signed written informed consent (approved by the Ethics Committee) obtained prior to study entry.