Phase I study of eniluracil, oral 5-fluororacil and gemcitabine in patients with advanced malignancy. Invest New Drugs 2002 Nov;20(4):377-82
Date
11/27/2002Pubmed ID
12448654DOI
10.1023/a:1020673928704Scopus ID
2-s2.0-0036829343 (requires institutional sign-in at Scopus site) 1 CitationAbstract
PURPOSE: The objectives of this trial were to assess the maximal tolerated dose and toxicity of the combination of oral eniluracil and 5-fluorouracil and intravenous gemcitabine.
PATIENTS AND METHODS: Patients with histologically confirmed, incurable malignancy (solid tumor or lymphoma) refractory to standard therapy or for which no standard therapy exists were enrolled. The treatment plan consisted of weekly gemcitabine for three weeks with twice daily dosing of 5-FU and eniluracil for 21 days beginning on day one of gemcitabine. Cycles repeated on an every four week schedule. The initial cohort received gemcitabine 800 mg/m2, oral 5-FU 0.6 mg/m2 and eniluracil 6.0 mg/m2.
RESULTS: Twenty-six patients were enrolled. Eight patients received less than 2 cycles of therapy. Hematologic and gastrointestinal toxicity predominated, with 48% of courses resulted in grade one or two neutropenia. Hematologic toxicity was dose limiting. One treatment related death occurred.
CONCLUSIONS: The combination of eniluracil, 5-fluorouracil and gemcitabine offers an oral alternative for 5-FU administration. The recommended phase II dose is gemcitabine 1000 mg/m2, 5FU 1.2 mg/m2 and eniluracil 12 mg/m2.
Author List
Morgan-Meadows S, Thomas JP, Mulkerin D, Berlin JD, Bailey H, Binger K, Volkman J, Alberti D, Feierabend C, Marrocha R, Arzoomanian RZ, Wilding GAuthor
James P. Thomas MD, PhD Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Administration, OralAntineoplastic Combined Chemotherapy Protocols
Deoxycytidine
Female
Fluorouracil
Humans
Lymphoma
Male
Middle Aged
Neoplasms
Patients
Uracil
