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Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
First Received: May 3, 2005   Last Updated: February 6, 2009   History of Changes
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00110123
  Purpose

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 Intervention Phase
Intraocular Melanoma
Metastatic Cancer
 Drug: fotemustine
Drug: isolated perfusion
 Phase III

Genetics Home Reference related topics: retinoblastoma
MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Fotemustine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Duration of survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Best response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Toxicity as assessed by CTCAE v3 [ Designated as safety issue: Yes ]

Estimated Enrollment: 262
Study Start Date: January 2005
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110123

Locations
Italy
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact: Contact Person     39-49-821-2105        
European Institute of Oncology Recruiting
Milan, Italy, 20141
Contact: Contact Person     39-02-5748-9861        
Istituto Nazionale per lo Studio e la Cura dei Tumori Recruiting
Naples, Italy, 80131
Contact: Contact Person     39-81-590-3230        
Universita di Siena Recruiting
Siena, Italy, 53100
Contact: Contact Person     39-0577-586-429        
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw Recruiting
Warsaw, Poland, 02-781
Contact: Contact Person     48-22-644-0200        
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Serge Leyvraz, MD     41-21-341-111     serge.leyvraz@chuv.ch    
United Kingdom, England
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: Contact Person     44-151-334-1155        
United Kingdom, Scotland
Ninewells Hospital Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Contact Person     44-1382-660-111        
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Serge Leyvraz, MD Centre Hospitalier Universitaire Vaudois
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000422353, EORTC-18021, EUDRACT-2004-002245-12
Study First Received: May 3, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00110123     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
liver metastases
ciliary body and choroid melanoma, medium/large size
iris melanoma
 extraocular extension melanoma
recurrent intraocular melanoma
metastatic intraocular melanoma

Study placed in the following topic categories:
Eye Neoplasms
Uveal Melanoma
Eye Diseases
Melanoma of the Choroid
Recurrence
Melanoma
Neuroendocrine Tumors
Ocular Melanoma
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neoplasm Metastasis
Intraocular Melanoma
Neuroepithelioma
Fotemustine
Nevus

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Eye Neoplasms
Antineoplastic Agents
Eye Diseases
Neoplasms, Nerve Tissue
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
 Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Fotemustine
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 07, 2009



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