E7070 in Treating Patients With Stage IV Melanoma
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)|
|Study Start Date:||February 2001|
|Primary Completion Date:||November 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014625
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Leon Berard|
|Lyon, France, 69373|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Naples, Italy, 80131|
|Norwegian Radium Hospital|
|Oslo, Norway, N-0310|
|Instituto Portugues de Oncologia de Francisco Gentil|
|Lisbon, Portugal, 1093|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||John F. Smyth, MD||Edinburgh Cancer Centre at Western General Hospital|
|Study Chair:||Steinar Aamdal, MD, PhD||Norwegian Radium Hospital|