Document Detail

Phase I study of Taxol, doxorubicin, plus granulocyte-colony stimulating factor in patients with metastatic breast cancer.
MedLine Citation:
PMID:  7517154     Owner:  NLM     Status:  MEDLINE    
The objective of this phase I trial was to determine the maximal tolerated dose (MTD) of Taxol and doxorubicin administered as a simultaneous intravenous infusion over 72 hours every 21 days. Granulocyte-colony stimulating factor (G-CSF) 10 micrograms/kg, was administered on days 4-18 of each cycle. The treated population consisted of metastatic breast cancer patients previously untreated with chemotherapy for metastatic disease, who had not received doxorubicin in the adjuvant setting and who had bidimensionally measurable disease. The MTD was determined to be 75 mg/m2 of doxorubicin and 160 mg/m2 of Taxol. The dose-limiting toxicity of the combination was clinical typhlitis in three of three patients. Other significant toxicities included grade 3 diarrhea at the higher dose levels and grade 4 neutropenia in all patients. Eighteen patients were treated on this initial phase I study. The overall response rate was 62%, with 6% complete responses and 56% partial responses. The combination of doxorubicin and Taxol by 72-hour continuous infusion with G-CSF is an active regimen in patients with metastatic breast cancer.
J S Fisherman; M McCabe; M Noone; F P Ognibene; B Goldspiel; D J Venzon; K H Cowan; J A O'Shaughnessy
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article    
Journal Detail:
Title:  Journal of the National Cancer Institute. Monographs     Volume:  -     ISSN:  1052-6773     ISO Abbreviation:  J. Natl. Cancer Inst. Monographs     Publication Date:  1993  
Date Detail:
Created Date:  1994-08-04     Completed Date:  1994-08-04     Revised Date:  2006-04-24    
Medline Journal Info:
Nlm Unique ID:  9011255     Medline TA:  J Natl Cancer Inst Monogr     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  189-94     Citation Subset:  IM    
Medicine Branch, National Cancer Institute, Bethesda, MD 20892.
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MeSH Terms
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Breast Neoplasms / drug therapy*
Doxorubicin / administration & dosage*
Granulocyte Colony-Stimulating Factor / administration & dosage*
Heart / drug effects
Neoplasm Metastasis
Paclitaxel / administration & dosage*,  adverse effects
Reg. No./Substance:
143011-72-7/Granulocyte Colony-Stimulating Factor; 23214-92-8/Doxorubicin; 33069-62-4/Paclitaxel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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