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- Title
Phase I study of 5-fluorouracil administered by protracted venous infusion, leucovorin, and pelvic radiation therapy.
- Authors
Martenson, James A.; Shanahan, Thomas G.; O'Connell, Michael J.; Cobau, Charles D.; Schroeder, Georgene; Burch, Patrick A.; Levitt, Ralph; Rowland, Kendrith M.; Martenson, J A; Shanahan, T G; O'Connell, M J; Cobau, C D; Schroeder, G; Burch, P A; Levitt, R; Rowland, K M Jr
- Abstract
<bold>Background: </bold>This study was designed to assess the toxicity of pelvic radiation therapy, 5-fluorouracil (5-FU) administered by protracted venous infusion, and leucovorin.<bold>Methods: </bold>Pelvic radiation therapy consisted of 50.4-54 gray (Gy) administered in 28-30 fractions. Systemic treatment consisted of leucovorin (10 mg daily) administered orally and protracted venous infusion of 5-FU. The initial daily 5-FU dose was 150 mg/m(2). Dose escalations were planned in increments of 25 mg/m(2).<bold>Results: </bold>Forty eligible patients were registered, of whom 37 were evaluable for chemoradiotherapy-related toxicity. Grade 3 or 4 toxicity secondary to radiation therapy, protracted venous infusion of 5-FU, and leucovorin occurred in 2 of 17 patients at a daily 5-FU dose of 150 mg/m(2), in 5 of 10 patients at a daily 5-FU dose of 175 mg/m(2), and in 5 of 10 patients at a daily 5-FU dose of 200 mg/m(2). Diarrhea was dose-limiting in 7 of 8 patients with Grade 4 toxicity. Venous thrombosis, a treatment-related complication not directly related to chemotherapy or radiation therapy, occurred in 5 of the 40 patients entered into this study. Four thromboses occurred at the site of a central catheter. No thrombotic complications occurred in the last 7 patients, who were given warfarin orally (1 mg daily) during treatment.<bold>Conclusions: </bold>Toxicity due to radiation therapy, protracted venous infusion of 5-FU, and leucovorin when 5-FU is given daily at a dose of 150 mg/m(2) is similar to that observed in current chemoradiotherapy regimens for patients with rectal carcinoma. This regimen will be considered as a possible investigational treatment arm of a future trial of adjuvant therapy for rectal carcinoma patients.
- Publication
Cancer (0008543X), 1999, Vol 86, Issue 4, p710
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/(SICI)1097-0142(19990815)86:4<710::AID-CNCR21>3.0.CO;2-5