Document Detail

UFT/leucovorin plus vinorelbine combination for advanced breast cancer.
MedLine Citation:
PMID:  11098494     Owner:  NLM     Status:  MEDLINE    
This phase I study was undertaken to define the maximum tolerated dose, the dose-limiting toxicity, and the recommended dose of UFT plus leucovorin and vinorelbine in combination treatment of patients with metastatic breast cancer previously treated with one chemotherapy regimen. The pharmacokinetics of UFT and vinorelbine were also evaluated. Patients were treated with escalating doses of UFT and vinorelbine, given every 4 weeks. At least three patients were treated at each dose level before escalating to the next level. As of September 1, 1999, 22 patients have been treated. Eighteen patients were evaluable for antitumor response. One patient had a complete response (which was obtained after three cycles); four patients had a partial response. The area under the concentration-time curve (AUC0-6 h) of 5-fluorouracil increase was more than dose-proportional. The AUC0-6 h values of fluorouracil were significantly higher than those noted for the four patients who developed dose-limiting toxicity at day 15. The removal of one administration of vinorelbine at dose levels 3 and 4 has allowed for increased UFT dosage and AUC0-6 h of fluorouracil, with no dose-limiting toxicity reported for these patients. No pharmacokinetic interaction between UFT and vinorelbine was observed.
P Fumoleau; R Déporte; P Kerbrat; J Bonneterre; P Fargeot
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article    
Journal Detail:
Title:  Oncology (Williston Park, N.Y.)     Volume:  14     ISSN:  0890-9091     ISO Abbreviation:  Oncology (Williston Park, N.Y.)     Publication Date:  2000 Oct 
Date Detail:
Created Date:  2001-02-12     Completed Date:  2001-03-01     Revised Date:  2006-04-24    
Medline Journal Info:
Nlm Unique ID:  8712059     Medline TA:  Oncology (Williston Park)     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  50-5     Citation Subset:  IM    
Medical Oncology Department, Centre René Gauducheau, Nantes, France.
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MeSH Terms
Administration, Oral
Antineoplastic Agents, Phytogenic / adverse effects,  pharmacokinetics,  therapeutic use*
Antineoplastic Combined Chemotherapy Protocols / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Area Under Curve
Breast Neoplasms / drug therapy*,  pathology
Dose-Response Relationship, Drug
Injections, Intravenous
Leucovorin / administration & dosage
Middle Aged
Tegafur / administration & dosage,  pharmacokinetics
Treatment Outcome
Uracil / administration & dosage,  pharmacokinetics
Vinblastine / adverse effects,  analogs & derivatives*,  pharmacokinetics,  therapeutic use*
Reg. No./Substance:
0/Antineoplastic Agents, Phytogenic; 17902-23-7/Tegafur; 58-05-9/Leucovorin; 66-22-8/Uracil; 71486-22-1/vinorelbine; 74578-38-4/1-UFT protocol; 865-21-4/Vinblastine

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

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