E7070 in Treating Patients With Stage IV Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00014625
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Institut Jules Bordet
🇧🇪Brussels, Belgium
Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Instituto Portugues de Oncologia de Francisco Gentil
🇵🇹Lisbon, Portugal
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples, Italy
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Leon Berard
🇫🇷Lyon, France
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom