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Titolo:
CLINICAL AND PHARMACOKINETIC STUDIES OF HIGH-DOSE LEVAMISOLE IN COMBINATION WITH 5-FLUOROURACIL IN PATIENTS WITH ADVANCED CANCER
Autore:
REID JM; KOVACH JS; OCONNELL MJ; BAGNIEWSKI PG; MOERTEL CG;
Indirizzi:
MAYO CLIN & MAYO FDN,DEPT ONCOL,ROOM 1321B,200 1ST ST SW ROCHESTER MN55905
Titolo Testata:
Cancer chemotherapy and pharmacology
fascicolo: 6, volume: 41, anno: 1998,
pagine: 477 - 484
SICI:
0344-5704(1998)41:6<477:CAPSOH>2.0.ZU;2-9
Fonte:
ISI
Lingua:
ENG
Soggetto:
FLUOROURACIL PLUS LEVAMISOLE; ADJUVANT THERAPY; COLON-CARCINOMA;
Keywords:
LEVAMISOLE; TOXICITY; PHARMACOKINETICS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
13
Recensione:
Indirizzi per estratti:
Citazione:
J.M. Reid et al., "CLINICAL AND PHARMACOKINETIC STUDIES OF HIGH-DOSE LEVAMISOLE IN COMBINATION WITH 5-FLUOROURACIL IN PATIENTS WITH ADVANCED CANCER", Cancer chemotherapy and pharmacology, 41(6), 1998, pp. 477-484

Abstract

Purpose: To determine the maximum tolerable dose (MTD) and activity of levamisole administered concurrently with 5-fluorouracil (5-FU) in astandard 5-day course. To determine the pharmacokinetics of levamisole during the course of treatment. Patients and methods: Levamisole wasadministered to 38 patients orally three times a day for 5 days concurrently with a course of 5-FU administered daily by rapid intravenous injection for 5 days. Toxicity was evaluated in 20 patients who received escalating doses of levamisole. The activity of the combination wasevaluated in 18 patients who received levamisole at the MTD with 5-FU. The pharmacokinetics of levamisole were characterized in ten patients at the MTD level. Results: Intractable vomiting, confusion and vertigo were the major dose-limiting toxicities. The MTD of oral levamisolewas 100 mg/m(2) administered three times a day concurrently with 450 mg/m(2) per day intravenous 5-FU for 5 consecutive days. Partial responses lasting 5 and 11 months were observed in 2/18 patients with measurable disease at the MTD. Peak plasma concentrations of 1 mu g/ml (range 0.6-1.3 mu g/ml) were achieved 90 min (range 60-360 min) after an oral dose of 100 mg/m(2) levamisole with a 3.5-fold accumulation noted following 4 days of administration. Peak plasma concentrations of p-hydroxylevamisole were about 5% of parent drug. Little parent drug (2-5%) was detected in urine. Conclusions: Levamisole may be administered safely with 5-FU at doses which are up to four to five times greater than those presently given in conventional regimens, The recommended dose of levamisole combined with 5-FU for future research protocols is 75mg/m(2) t.i.d for 5 days.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 06/07/20 alle ore 05:56:05