A phase II study evaluating CAVi (cyclophosphamide, adriamycin, vincristine) potentiated or not by amphotericin B entrapped into sonicated liposomes, as salvage therapy for small cell lung cancer

Abstract Two consecutive trials were conducted, testing the CAVi (cyclophosphamide 1 g/m 2 ; doxorubicin (adriamycin) 45 mg/m 2 ; vincristine 1.4 mg/m 2 ; all i.v. on day 1; every 3 weeks) combination as salvage therapy for small cell lung cancer (SCLC) after first line treatment with etoposide plus vindesine with or without cisplatin. In the first study, CAVi was used alone. In 45 evaluable patients, 6 objective responses were observed (13%; Confidence Limits (C.L.): 5.1–20.8). In the second study, CAVi was potentiated with 2 mg/kg of ampholiposomes given i.v., 24 h prior to chemotherapy. Ampholiposomes consisted of amphotericin B entrapped into sonicated liposomes made of egg lecithin, cholesterol and stearylamine in the molar ratio 4:3:1 (lipid concentration: 20 mg/ml). Among 11 evaluable patients, 6 objective responses were observed (55%; Confidence Limits: 23.4–83.3) and toxicity was not increased. These preliminary results suggest that ampholiposomes might overcome resistance to chemotherapy in SCLC and should encourage controlled studies.