NCT00110123TerminatedPhase 3
Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
European Organisation for Research and Treatment of Cancer - EORTC16 sites in 4 countries171 target enrollmentStarted: January 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 171
- Locations
- 16
- Primary Endpoint
- Duration of survival
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different ways may kill more tumor cells. It is not yet known whether giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic arterial infusion in treating liver metastases.
PURPOSE: This randomized phase III trial is studying intravenous infusion of fotemustine to see how well it works compared to hepatic arterial infusion of fotemustine in treating patients with unresectable liver metastases from eye melanoma.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •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
- •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
- •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
- •Recovered from prior major surgery
- •No prior antineoplastic drugs for metastatic disease
- •More than 4 weeks since prior investigational drugs
- •No other concurrent anticancer agents or therapies
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Duration of survival
Secondary Outcomes
- Progression-free survival
- Best response as assessed by RECIST criteria
- Duration of response
- Toxicity as assessed by CTCAE v3
Investigators
Study Sites (16)
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