Intermittent regional infusion of chemotherapy for pancreatic adenocarcinoma. Phase I and II pilot study

Nineteen patients with unresectable and metastatic adenocarcinoma of the pancreas and ampulla of Vater were treated with intermittent regional infusion of the celiac axis (CAI) with the combination of 5-fluorouracil, adriamycin, mitomycin-C, and streptozotocin (FAM-S). Three schedules with escalating doses were investigated. The arterial infusion was repeated at 4 weeks, and in responding and stable patients, I.V. FAM-S was continued at monthly intervals. Twelve patients had measurable disease, and in this group one complete response and seven partial responses occurred. Median duration of response was 6+ months and median survival for all patients was 5.2 months. Four patients had catheter-related complications (emboli, three, sepsis, one). Hematologic and gastrointestinal toxicity was minimal. Celiac artery infusion with FAM-S in locally extensive and metastatic adenocarcinoma of the pancreas and ampulla of Vater is a relatively simple procedure associated with low incidence of serious complications and toxicity but a higher response rate than previously reported. Induction of response with CAI and subsequent maintenance therapy with intravenous chemotherapy is under investigation.