A phase I trial combining oral cisplatin (CP Ethypharm) with radiotherapy in patients with locally advanced head and neck squamous cell carcinoma.

Détails

ID Serval
serval:BIB_4CE4DCBC4554
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
A phase I trial combining oral cisplatin (CP Ethypharm) with radiotherapy in patients with locally advanced head and neck squamous cell carcinoma.
Périodique
Radiotherapy and Oncology
Auteur(s)
Tao Y., Rezaï K., Brain E., Etessami A., Lusinchi A., Temam S., Urien S., Van M.L., Vauzelle-Kervroedan F., Lokiec F., Daly-Schveitzer N., Bourhis J.
ISSN
1879-0887 (Electronic)
ISSN-L
0167-8140
Statut éditorial
Publié
Date de publication
2011
Peer-reviewed
Oui
Volume
98
Numéro
1
Pages
42-47
Langue
anglais
Notes
Publication types: Clinical Trial, Phase I ; Journal Article ; Multicenter StudyPublication Status: ppublish
Résumé
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 7 weeks (4 treatment cycles) in combination with radiotherapy. Eighteen patients with locally advanced HNSCC were allocated to four cisplatin dose levels: 10 mg/m(2)/day: 4 patients; 15 mg/m(2)/day: 4, 20 mg/m(2)/day: 5 and 25 mg/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 25 mg/m(2) level (two grade 2 renal toxicities, one grade 3 GI and renal toxicities), one at 20 mg/m(2) level (grade 3 GI disorders), one at 10 mg/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 25 mg/m(2)/day, MTD was reached and the recommended dose for phase II studies was determined as 20 mg/m(2)/day.
Mots-clé
Administration, Oral, Carcinoma/drug therapy, Carcinoma/radiotherapy, Carcinoma, Squamous Cell, Cisplatin/administration & dosage, Cisplatin/adverse effects, Combined Modality Therapy, Female, Head and Neck Neoplasms/drug therapy, Head and Neck Neoplasms/radiotherapy, Humans, Male, Maximum Tolerated Dose, Middle Aged, Neoplasms, Squamous Cell/drug therapy, Neoplasms, Squamous Cell/radiotherapy, Radiotherapy Dosage
Pubmed
Web of science
Création de la notice
01/12/2014 17:05
Dernière modification de la notice
20/08/2019 14:01
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