Combined Simvastatin and Paclitaxel in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy

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PRIMARY OBJECTIVES: I.To assess disease control rate (DCR) after treatment. SECONDARY OBJECTIVES: I.To assess best overall response rate (ORR) after treatment. II.To evaluate the progression-free survival (PFS) of patients with extensive stage-small cell lung cancer (ES-SCLC) treated with paclitaxel...

PRIMARY OBJECTIVES: I.To assess disease control rate (DCR) after treatment. SECONDARY OBJECTIVES: I.To assess best overall response rate (ORR) after treatment. II.To evaluate the progression-free survival (PFS) of patients with extensive stage-small cell lung cancer (ES-SCLC) treated with paclitaxel + simvastatin or with paclitaxel alone. III.To estimate overall survival (OS) of patients with ES-SCLC. IV. To evaluate the toxicity profile of paclitaxel + simvastatin. EXPLORATORY OBJECTIVES: I.To evaluate biomarkers correlatives. II.To explore the mechanism of paclitaxel + simvastatin in the treatment of chemotherapy-resistant participants with ES-SCLC. OUTLINE: Patients are divided into two arms. ARM A: Participants received intravenous infusions of Paclitaxel 260 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle in combination with oral simvastatin (20mg daily) until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor. ARM B:Participants received intravenous infusions of Paclitaxel 260 mg/m^2 alone on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

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