Document Detail

A multi-center phase Ib study of oxaliplatin (NSC#266046) in combination with fluorouracil and leucovorin in pediatric patients with advanced solid tumors.
MedLine Citation:
PMID:  23024067     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Platinum agents have been used for a variety of cancers, including pivotal use in pediatric tumors for many years. Oxaliplatin, a third generation platinum, has a different side effect profile and may provide improved activity in pediatric cancers.
PROCEDURE: Patients 21 years or younger with progressive or refractory malignant solid tumors, including tumors of the central nervous system were enrolled on this multi-center open label, non-randomized Phase 1 dose escalation study. The study used a standard 3 + 3 dose escalation design with 2 dose levels (85 and 100 mg/m(2) ) with an expansion cohort of 15 additional patients at the recommended dose. Patients received oxaliplatin at the assigned dose level and 5-fluorouracil (5-FU) bolus 400 mg/m(2) followed by a 46-hour 5-FU infusion of 2,400 mg/m(2) every 14 days. The leucovorin dose was fixed at 400 mg/m(2) for all cohorts.
RESULTS: Thirty-one evaluable patients were enrolled, 8 at 85 mg/m(2) and 23 at 100 mg/m(2) for a total of 121 courses. The median age was 12 years (range 2-19 years). The main toxicities were hematologic, primarily neutrophils and platelets. The most common non-hematologic toxicities were gastrointestinal. Stable disease was noted in 11 patients (54% of evaluable patients) and 1 confirmed partial response in a patient with osteosarcoma.
CONCLUSIONS: The maximum planned dose of oxaliplatin at 100 mg/m(2) per dose in combination with 5-FU and leucovorin was safe and well tolerated and in this patient population. This combination demonstrated modest activity in patients with refractory or relapsed solid tumor and warrants further study. Pediatr Blood Cancer 2013;60:230-236. © 2012 Wiley Periodicals, Inc.
Margaret E Macy; Tracey Duncan; James Whitlock; Stephen P Hunger; Jessica Boklan; Aru Narendren; Cynthia Herzog; Robert J Arceci; Rochelle Bagatell; Tanya Trippett; Uwe Christians; Katherine Rolla; S Percy Ivy; Lia Gore;
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural     Date:  2012-09-28
Journal Detail:
Title:  Pediatric blood & cancer     Volume:  60     ISSN:  1545-5017     ISO Abbreviation:  Pediatr Blood Cancer     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2012-12-14     Completed Date:  2013-03-06     Revised Date:  2014-06-27    
Medline Journal Info:
Nlm Unique ID:  101186624     Medline TA:  Pediatr Blood Cancer     Country:  United States    
Other Details:
Languages:  eng     Pagination:  230-6     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
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MeSH Terms
Antineoplastic Combined Chemotherapy Protocols / pharmacokinetics,  therapeutic use*
Child, Preschool
Dose-Response Relationship, Drug
Fluorouracil / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use
Leucovorin / administration & dosage,  adverse effects,  pharmacokinetics
Maximum Tolerated Dose
Neoplasms / drug therapy*,  pathology*
Organoplatinum Compounds / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use
Grant Support
K12 CA086913/CA/NCI NIH HHS; K12 CA086913-08/CA/NCI NIH HHS; T32 CA082086/CA/NCI NIH HHS
Reg. No./Substance:
0/Organoplatinum Compounds; 63121-00-6/oxaliplatin; Q573I9DVLP/Leucovorin; U3P01618RT/Fluorouracil

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

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