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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00110123 |
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 |
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Intraocular Melanoma Metastatic Cancer |
Drug: fotemustine Drug: isolated perfusion |
Phase III |
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 |
Estimated Enrollment: | 262 |
Study Start Date: | January 2005 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 262 patients (131 per treatment arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed liver metastases secondary to uveal melanoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study Chair: | Serge Leyvraz, MD | Centre Hospitalier Universitaire Vaudois |
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 |
liver metastases ciliary body and choroid melanoma, medium/large size iris melanoma |
extraocular extension melanoma recurrent intraocular melanoma metastatic intraocular melanoma |
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 |
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 |