Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
- Compare overall survival of patients with surgically incurable or unresectable liver
metastases secondary to uveal melanoma treated with fotemustine administered as an
intravenous infusion vs an intra-arterial hepatic perfusion.
- Compare progression-free survival of patients treated with this drug.
- Compare the response rate in patients treated with this drug.
- Compare the duration of objective response in patients treated with this drug.
- Compare the patterns of progression in patients treated with this drug.
- Compare treatment-related toxic effects and catheter-related complications in patients
treated with this drug.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to participating center, lactic dehydrogenase level (normal vs abnormal), and WHO
performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fotemustine IV over 1 hour on days 1, 8, and 15 (induction
course). Beginning on day 50, patients receive maintenance courses of fotemustine IV
over 1 hour every 21 days in the absence of disease progression or unacceptable
- Arm II: Patients receive fotemustine by a 4-hour intra-arterial (IA) hepatic perfusion
on days 1, 8, 15, and 22 (induction course). Beginning on day 57, patients receive
maintenance courses of fotemustine by a 4-hour IA hepatic perfusion every 21 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 9 weeks for survival.
PROJECTED ACCRUAL: A total of 262 patients (131 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Duration of survival
Serge Leyvraz, MD
Centre Hospitalier Universitaire Vaudois
United States: Federal Government