Document Detail


Phase I/II study of intraperitoneal floxuridine and platinums (cisplatin and/or carboplatin).
MedLine Citation:
PMID:  9264578     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Previous studies have shown that intraperitoneal (i.p.) floxuridine (FUDR) is tolerated at a dose of 3 g x 3 days given in 1.5-2 L of normal saline (NS). In a randomized phase II trial by the Southwest Oncology Group, this treatment was selected for further study because of a favorable 1-year progression-free survival. We have now evaluated ip FUDR in full doses combined with i.p. cisplatin given on the third day at a dose of 60 mg/m2 in 500 mL of NS. Intraperitoneal carboplatin was partially or fully substituted for i.p. cisplatin in patients with symptomatic neuropathies. All patients also received i.p. leucovorin, as previously piloted for fluoropyrimidine modulation. Seven patients with symptomatic ascites or measurable tumors were entered, as were 11 asymptomatic patients with minimal residual (< or = 1 cm) epithelial ovarian cancer. Six cycles of the combination of i.p. FUDR + cisplatin were completed in three patients; however, the combination of FUDR with both platinums was particularly well tolerated. Intraperitoneal FUDR + carboplatin (AUC of 5) was associated with some grade 3 and 4 thrombocytopenia and neutropenia. Eight of these 11 patients are alive, and 3 have been continuously with no evidence of disease exceeding 32 months. The regimen of i.p. FUDR + i.p. cisplatin (or i.p. FUDR with both platinums) is suitable for a phase III trial testing i.p. therapy either from the outset (e.g., i.p. up front) or after achieving clinical complete responses from initial treatment without intervening relapse (i.e., i.p. consolidation) in comparison to i.p. cisplatin.
Authors:
F M Muggia; S Jeffers; L Muderspach; L Roman; R Rosales; S Groshen; T Safra; C P Morrow
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Controlled Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Gynecologic oncology     Volume:  66     ISSN:  0090-8258     ISO Abbreviation:  Gynecol. Oncol.     Publication Date:  1997 Aug 
Date Detail:
Created Date:  1997-09-22     Completed Date:  1997-09-22     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0365304     Medline TA:  Gynecol Oncol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  290-4     Citation Subset:  IM    
Affiliation:
University of Southern California-Kenneth Norris, Jr., Comprehensive Cancer Center, Los Angeles 90033, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antimetabolites, Antineoplastic / administration & dosage
Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
Carboplatin / administration & dosage
Cisplatin / administration & dosage
Disease Progression
Female
Floxuridine / administration & dosage
Humans
Infusions, Parenteral
Middle Aged
Neoplasm Metastasis
Neoplasm Recurrence, Local / drug therapy
Ovarian Neoplasms / drug therapy*,  pathology
Survival Rate
Grant Support
ID/Acronym/Agency:
2P30-CA14089-18/CA/NCI NIH HHS; R01/50412-04//PHS HHS
Chemical
Reg. No./Substance:
0/Antimetabolites, Antineoplastic; 15663-27-1/Cisplatin; 41575-94-4/Carboplatin; 50-91-9/Floxuridine

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


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