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M9471089.TXT
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1994-08-09
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Document 1089
DOCN M9471089
TI A trial of Paclitaxel (TAXOL) in patients with HIV-associated Kaposi's
sarcoma (KS) (Meeting abstract).
DT 9409
AU Saville MW; Lietzau J; Wilson W; Pluda J; Bailey J; Cohen R; Feigal E;
Broder S; Yarchoan R; NCI, Bethesda, MD 20892
SO Proc Annu Meet Am Soc Clin Oncol; 13:A20 1994. Unique Identifier :
AIDSLINE ICDB/94600017
AB KS is a frequent cause of severe morbidity and death in patients with
human immunodeficiency virus (HIV) infection. Current therapies are
often poorly tolerated, and new drugs are needed for this condition. It
has been observed that inhibitors of microtubule assembly are active
against KS, and this led us to consider paclitaxel, an agent that causes
microtubule polymerization, as a potential therapy for this disorder. In
in vitro studies, we found that paclitaxel inhibited the proliferation
of a KS-derived spindle cell line at a concentration of approximately 10
nM. As a prelude to conducting a formal Phase II study, we treated three
KS pts with 105 mg/m2 paclitaxel by continuous 96 hr infusion every 21
days. Toxicity consisted of moderate myelosuppression, alopecia, one
acute skin rash, and four episodes of central venous catheter infection.
Each of two evaluable pts, including one with pulmonary involvement,
achieved a partial response (PR). We subsequently initiated a Phase II
trial of paclitaxel 135 mg/m2, administered as a 3 hour infusion by
peripheral catheter, with dose escalation each cycle as tolerated to a
maximum of 155 mg/m2. The 3 hour infusion schedule was chosen as being
more practical than a 96-hr infusion, and to avoid the problem of line
infections associated with an indwelling catheter. Patients entered on
this study could have had a maximum of one prior course of cytotoxic
chemotherapy, and could have visceral disease which was not immediately
life-threatening. Six patients have been entered to date. Despite
limited follow up (average 2.6 cycles of treatment), one patient has
attained a PR and none have had progression. Two patients developed a
skin rash 10 days after treatment, and one developed fever, malaise, and
thrombocytopenia 18-24 days after treatment for two consecutive cycles.
Otherwise, myelosuppression has been brief and not associated with
infection. Updated results will be presented.
DE Cell Division/DRUG EFFECTS Dose-Response Relationship, Drug Follow-Up
Studies HIV Infections/*DRUG THERAPY/PATHOLOGY Human Infusions,
Intravenous Sarcoma, Kaposi's/*DRUG THERAPY/PATHOLOGY Skin
Neoplasms/*DRUG THERAPY/PATHOLOGY Taxol/*ADMINISTRATION &
DOSAGE/ADVERSE EFFECTS MEETING ABSTRACT CLINICAL TRIAL CLINICAL
TRIAL, PHASE II
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).