Evaluation of combination chemotherapy and phase II agents in pancreatic adenocarcinoma. A Southwest Oncology Group study

Abstract

Background: Pancreatic carcinoma responds poorly to conventional chemotherapy. To identify potentially useful agents, a sequence of clinical trials were done.

Methods: A series of Phase II randomized trials were done by the Southwest Oncology Group in which patients with metastatic or advanced pancreatic cancer were randomized to receive single agents (methylglyoxal-bis-guanylhydrazone [MGBG], dihydroxyanthracenedione [DHAD], and aziridinylbenzoquinone [AZQ]) or a combined regimen of 5-fluorouracil, doxorubicin, mitomycin C, and streptozotocin (FAM-S). Toxicity, response, and survival were determined.

Results: Seventy-one patients received FAM-S and 82, the Phase II single agents. Response rates (95% confidence intervals) for the various treatments were: FAM-S, 11% (0%, 21%); MGBG, 6% (0.8%, 21%); DHAD, 0% (0%, 12%); and AZQ, 0% (0%, 16%). The median survival times were: FAM-S Group, 4.8 months and Phase II agent Group, 3.4 months.

Conclusions: The FAM-S regimen and the Phase II agents tested did not have substantial antitumor activity in pancreatic cancer. The use of new agents as initial therapy is reasonable.