A randomized phase II trial comparing epirubicin, cisplatin, and capecitabine versus the combination of epirubicin, cisplatin, and capecitabine with pravastatin in patients with irresectable or metastatic gastric carcinoma.

N/A

Treatment with capecitabine, combined with epirubicin and cisplatin (ECC) has been proven to improve time to progression and survival in patients with advanced, non-resectable gastric cancer. HMG-CoA-reductase inhibitors have anti-tumor activity in vitro against gastric carcinoma. Statins furthermore interact synergistically with cisplatin, 5-FU and doxorubicin both in vitro and animal models. As prognosis of advanced irresectable gastric cancer is poor, it is worthwhile to study whether the combination of ECC and pravastatin is an option for these patients.

Control arm (ECC): epirubicin 50 mg/m2 i.v., day 1, Cisplatin 60 mg/m2 i.v., day 1, 3-hour infusion, Capecitabine 1000 mg/m2 in the morning and 1000 mg/m2 in the evening, p.o., day 1-14. ECC will be given at 3-week intervals, for a maximum total of 6 cycles.
Experimental arm (ECC plus pravastatin): Epirubicin 50 mg/m2 i.v., day 1, Cisplatin 60 mg/m2 i.v., day 1, 3-hour infusion, Capecitabine 1000 mg/m2 in the morning and 1000 mg/m2 in the evening, p.o., day 1-14. ECC will be given at 3-week intervals, for a maximum total of 6 cycles. In addition, patients will receive daily 40 mg pravastatin, from day 1 to 1 week after the capecitabine of the last ECC.