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
Institution
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
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.
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 18:05
Dernière modification de la notice
20/08/2019 15:01