Phase II protocol for the evaluation of new treatments in patients with advanced gastric carcinoma: results of ECOG 5282

The study was a Phase II randomized study to evaluate the efficacy of new a gents for the treatment of advanced gastric carcinoma. Patients were random ized to receive single agent chemotherapy with mitoxantrone, etoposide, acl acinomycin-A or spirogermanium. The patients were stratified by prior use o f chemotherapy, prior doxorubicin use and ECOG performance status. Patients with a history of cardiac disease or prior doxorubicin exceeding a dose of 400 mg/m(2) were restrictively randomized to sopirogermanium or etoposide only. One hundred and fourteen patients were registered for the study. Amon g 98 evaluable patients there were only two partial responses (both in the etoposide arm), and one complete response in the mitoxantrone arm. The medi an survival on the study was 3.3 months. One hundred and six patients were analyzable for toxicity. There were four treatment-related deaths and four lifethreatening toxicities. Because of low response rates and relatively hi gh toxicities the studied compounds were not deemed worth further investiga tion for advanced gastric cancer.