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M94A3015.TXT
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1994-10-25
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Document 3015
DOCN M94A3015
TI A phase II study of oral etoposide (VP-16) in AIDS-related Kaposi's
sarcoma (KS).
DT 9412
AU Mans D; Sprinz E; Sander I; Kalakun F; Jung G; Prolla G; Schwartsmann G;
South American Office for Anticancer Drug Development, Brasil.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):173 (abstract no. PB0118). Unique
Identifier : AIDSLINE ICA10/94369560
AB OBJECTIVE: To access the toxicity and antitumor activity of oral VP-16
monotherapy in relation to plasma pharmacokinetics in patients with
advanced AIDS-related KS. POPULATION & METHODS: Sixteen homo/bisexual
male patients with AIDS-related KS NYU stage HIA-IVB were enrolled in
the study. The mean age was 36 years (21-50) and performance status 1
(0-2). Oral VP-16 was administered at the dose of 25 mg/m2 bid for 7
days followed one week rest. In case of leucopenia grade 3-4 and/or
thrombocytopenia, there was a 50% dose reduction. RESULTS: Complete and
partial responses were achieved in 3 and 5 patients, respectively (56%).
The mean duration response was 12 weeks (4-48 weeks). The most common
adverse effects were leucopenia and nausea, and in 5 (31%) patients
etoposide was reduced or discontinued due to severe toxicity. The plasma
concentration versus time plots showed a mono- (2 patients) or biphasic
decay (3 patients), consistent with a two- or three-compartment open
model, respectively. Cytotoxic plasma concentrations (> 1 microgram/ml),
were maintained for at least 6 hours during each administration. Mean
peak levels after 2 hours were 2.1 micrograms/ml (range 1.3-2.5), which
are usually bellow myelotoxic levels (> 3 micrograms/ml). The mean
elimination half-life was 6.9 hours (range 4.5-9.3). CONCLUSIONS: Oral
VP-16 is effective, relatively safe and well-tolerated in AIDS-related
KS. This is probably due to the prolonged maintenance of cytotoxic
plasma concentrations of the drug while avoiding toxic peak levels. Oral
VP-16 is suitable for outpatient treatment. Future studies will exploit
its use as a tid oral administration with a 25% dose escalation.
DE Acquired Immunodeficiency Syndrome/BLOOD/*DRUG THERAPY Administration,
Oral Adult Bisexuality Dose-Response Relationship, Drug Drug
Administration Schedule Etoposide/*ADMINISTRATION & DOSAGE/ADVERSE
EFFECTS/ PHARMACOKINETICS Homosexuality Human Male Metabolic
Clearance Rate Middle Age Sarcoma, Kaposi's/BLOOD/*DRUG THERAPY
CLINICAL TRIAL CLINICAL TRIAL, PHASE II MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).