Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
18 Years
N/A
Both
Intraocular Melanoma, Metastatic Cancer
Trial Information
Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
OBJECTIVES:
Primary
- 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.
Secondary
- 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
toxicity.
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed liver metastases secondary to uveal
melanoma
- Surgically incurable or unresectable disease
- No detectable extrahepatic metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- ALT and AST < 5 times ULN
- Alkaline phosphatase < 5 times ULN
- Gamma-glutamyltransferase < 5 times ULN
- Lactic dehydrogenase < 5 times ULN
Renal
- BUN < 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No uncontrolled angina pectoris
- No myocardial infarction within the past 6 months
- No uncontrolled high blood pressure
- No evolutive intracranial hypertension
- No other severe cardiac disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active gastroduodenal ulcer
- No diabetes
- No active or uncontrolled infection
- No psychological, familial, sociological, or geographical condition that would
preclude study compliance and follow-up
- No other uncontrolled severe medical condition
- No other malignancy within the past 5 years except surgically cured carcinoma in situ
of the cervix or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunologic or biologic therapy
Chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for metastatic disease
- No concurrent radiotherapy
Surgery
- Recovered from prior major surgery
Other
- No prior antineoplastic drugs for metastatic disease
- More than 4 weeks since prior investigational drugs
- No other concurrent anticancer agents or therapies
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Duration of survival
Safety Issue:
No
Principal Investigator
Serge Leyvraz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospitalier Universitaire Vaudois
Authority:
United States: Federal Government
Study ID:
EORTC-18021
NCT ID:
NCT00110123
Start Date:
January 2005
Completion Date:
Related Keywords:
- Intraocular Melanoma
- Metastatic Cancer
- liver metastases
- ciliary body and choroid melanoma, medium/large size
- iris melanoma
- extraocular extension melanoma
- recurrent intraocular melanoma
- metastatic intraocular melanoma
- Melanoma
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Uveal Neoplasms
- Liver Neoplasms
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