Document Detail

A phase I trial combining oral cisplatin (CP Ethypharm) with radiotherapy in patients with locally advanced head and neck squamous cell carcinoma.
MedLine Citation:
PMID:  21176985     Owner:  NLM     Status:  In-Data-Review    
PURPOSE: To determine the maximum tolerated dose (MTD) of oral cisplatin (CP Ethypharm®) in combination with radiotherapy in head and neck squamous cell carcinoma (HNSCC) and the recommended dose for phase II trials.
PATIENTS AND METHODS: Phase I, multicenter, open-labelled, non-comparative and dose escalating trial. CP Ethypharm® was administered on five consecutive days every other week for 7weeks (4 treatment cycles) in combination with radiotherapy. Eighteen patients with locally advanced HNSCC were allocated to four cisplatin dose levels: 10mg/m(2)/day: 4 patients; 15mg/m(2)/day: 4, 20mg/m(2)/day: 5 and 25mg/m(2)/day: 5. The inclusion of patients was dictated by occurrence of dose limiting toxicities (DLTs) at each dosing level.
RESULTS: The most frequently experienced AEs were gastrointestinal (GI) disorders. Five DLTs were observed, including three at 25mg/m(2) level (two grade 2 renal toxicities, one grade 3 GI and renal toxicities), one at 20mg/m(2) level (grade 3 GI disorders), one at 10mg/m(2) level (grade 4 mucositis). PK analysis showed no significant difference of C(max) values between day 1 and day 5 of treatment at each dose level (total & ultrafilterable platinum).
CONCLUSION: Due to 3 DLTs experienced at 25mg/m(2)/day, MTD was reached and the recommended dose for phase II studies was determined as 20mg/m(2)/day.
Yungan Tao; Keyvan Rezaï; Etienne Brain; Atoussa Etessami; Antoine Lusinchi; Stephane Temam; Saik Urien; Marie-Louise Vo Van; Françoise Vauzelle-Kervroedan; François Lokiec; Nicolas Daly-Schveitzer; Jean Bourhis
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Publication Detail:
Type:  Journal Article     Date:  2010-12-20
Journal Detail:
Title:  Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology     Volume:  98     ISSN:  1879-0887     ISO Abbreviation:  Radiother Oncol     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-01-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8407192     Medline TA:  Radiother Oncol     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  42-7     Citation Subset:  IM    
Copyright Information:
Copyright © 2010. Published by Elsevier Ireland Ltd.
Institute Gustave-Roussy, Villejuif, France.
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