RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.
OBJECTIVES: I. Determine the therapeutic activity of E7070 in terms of objective response, duration of response, and progression-free survival of patients with metastatic melanoma. II. Determine the acute side effects of this drug in these patients. III. Determine the pharmacokinetic parameters of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive E7070 IV over 1 hour. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks. PROJECTED ACCRUAL: A total of 19-24 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
28
Kaiser Franz Josef Hospital
Vienna, Austria
Institut Jules Bordet
Brussels, Belgium
Centre Jean Perrin
Clermont-Ferrand, France
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Centre Leon Berard
Lyon, France
Centre Eugene Marquis
Rennes, France
Medizinische Hochschule Hannover
Hanover, Germany
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy
Norwegian Radium Hospital
Oslo, Norway
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, Portugal
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
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