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Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110123
Recruitment Status : Terminated (low accrual)
First Posted : May 4, 2005
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Intraocular Melanoma Metastatic Cancer Drug: fotemustine Drug: isolated perfusion Phase 3

Detailed Description:



  • 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
Study Start Date : January 2005
Actual Primary Completion Date : June 2011

Primary Outcome Measures :
  1. Duration of survival

Secondary Outcome Measures :
  1. Progression-free survival
  2. Best response as assessed by RECIST criteria
  3. Duration of response
  4. Toxicity as assessed by CTCAE v3

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed liver metastases secondary to uveal melanoma

    • Surgically incurable or unresectable disease
  • No detectable extrahepatic metastases



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • 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


  • 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


Biologic therapy

  • No concurrent immunologic or biologic therapy


  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110123

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European Institute of Oncology
Milan, Italy, 20141
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Universita di Siena
Siena, Italy, 53100
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland, 02-781
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Serge Leyvraz, MD Centre Hospitalier Universitaire Vaudois
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00110123    
Other Study ID Numbers: EORTC-18021
2004-002245-12 ( EudraCT Number )
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
liver metastases
ciliary body and choroid melanoma, medium/large size
iris melanoma
extraocular extension melanoma
recurrent intraocular melanoma
metastatic intraocular melanoma
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents