Robert Beauchamp
Principal Investigator
Last active: 10/31/2018

Eastern Cooperative Oncology Group Phase I trial of protracted venous infusion fluorouracil plus weekly gemcitabine with concurrent radiation therapy in patients with locally advanced pancreas cancer: a regimen with unexpected early toxicity.

Talamonti MS, Catalano PJ, Vaughn DJ, Whittington R, Beauchamp RD, Berlin J, Benson AB
J Clin Oncol. 2000 18 (19): 3384-9

PMID: 11013279 · DOI:10.1200/JCO.2000.18.19.3384

PURPOSE - We performed a phase I trial of protracted venous infusion (PVI) fluorouracil (5-FU) plus weekly gemcitabine with concurrent radiation therapy in patients with locally advanced pancreas cancer to determine the maximum-tolerated dose of gemcitabine that could be safely administered. We also sought to identify the toxicities associated with this treatment protocol.

PATIENTS AND METHODS - Seven patients with locally advanced pancreas cancer were treated with planned doses of radiation (59.4 Gy) and PVI of 5-FU (200 mg/m(2)/d) with gemcitabine doses of 50 to 100 mg/m(2)/wk.

RESULTS - Two of three patients at the 100-mg/m(2)/wk dose level experienced dose-limiting toxicity (DLT), as did three of four at the 50-mg/m(2)/wk dose level. One patient experienced a mucocutaneous reaction described as a Stevens-Johnson syndrome that was attributed to chemotherapy. Three patients developed gastric or duodenal ulcers with severe bleeding requiring transfusion. One patient developed severe thrombocytopenia lasting longer than 4 weeks. Three of the five episodes of DLT developed at radiation doses < or = 36 Gy.

CONCLUSION - Based on this experience, we cannot recommend further investigation of regimens incorporating gemcitabine into regimens of radiation with PVI 5-FU. The mechanism of this synergistic toxicity remains to be determined.

MeSH Terms (17)

Adenocarcinoma Aged Antineoplastic Combined Chemotherapy Protocols Combined Modality Therapy Deoxycytidine Dose-Response Relationship, Drug Dose-Response Relationship, Radiation Drug Administration Schedule Female Fluorouracil Humans Infusions, Intravenous Male Middle Aged Pancreatic Neoplasms Radiotherapy Survival Analysis

Connections (2)

This publication is referenced by other Labnodes entities:

Links