E7070 in Treating Patients With Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00014625|
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : July 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: indisulam||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Official Title:||Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||November 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|