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M9471077.TXT
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1994-08-09
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Document 1077
DOCN M9471077
TI Phase IV clinical evaluation of recombinant human erythropoietin
(r-HuEPO) in anemic cancer patients receiving chemotherapy (Meeting
abstract).
DT 9409
AU Bukowski R; Glaspy J; Steinberg D; Taylor CW; Vadhan-Raj S; Sarokhan B;
Lonczak L; Cleveland Clinic Foundation, Cleveland, OH
SO Proc Annu Meet Am Soc Clin Oncol; 13:A1594 1994. Unique Identifier :
AIDSLINE ICDB/94601587
AB In a series of controlled clinical trials, r-HuEPO increased hematocrit
and decreased transfusion requirements after the first month of therapy
in anemic cancer patients undergoing chemotherapy. The present open
label Phase IV study, conducted mainly in community-based oncology
practices, was undertaken to confirm the results of these controlled
clinical trials, to familiarize physicians with a dose level (150 U/kg
tiw) somewhat higher than that used in CRF and HIV, and to reflect
actual practices used in treating anemic cancer patients receiving
chemotherapy. Approximately 520 physicians enrolled over 2000 patients
from July to December 1993. Baseline characteristics of the 1101
patients for whom data are complete are shown in a table. These
characteristics are similar to those for the patients treated in the
controlled clinical trials in terms of age, mean initial hematocrit and
transfusion requirements. The study population includes patients
diagnosed with various tumor types including hematologic and
nonhematologic. Patients with myeloid malignancies, such as the acute
leukemias, were excluded. The chemotherapy regimens administered
included cisplatin (N=223), carboplatin (N=209) and nonplatinum (N=669)
agents. Patients are treated for 4 months at a starting dose of r-HuEPO
(PROCRIT [Epoetin alfa]) of 150 U/kg sc tiw. If response is not
satisfactory after 8 weeks, the dose can be increased to 300 U/kg tiw.
Effectiveness is being evaluated by improvement in hematocrit over time,
transfusion requirements and quality of life as measured by a linear
analog scale. The study is in progress and the results of this
nationwide trial remain preliminary.
DE Anemia/CHEMICALLY INDUCED/*THERAPY Antineoplastic Agents/*ADVERSE
EFFECTS Erythropoietin/THERAPEUTIC USE Female Human Male Middle Age
Neoplasms/*DRUG THERAPY Recombinant Proteins/THERAPEUTIC USE MEETING
ABSTRACT CLINICAL TRIAL, PHASE IV
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).