NCT00014625

E7070 in Treating Patients With Stage IV Melanoma

Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	indisulam

Timeline

• Start date: 2001-02-01
• Primary completion: 2001-11-01
• First posted: 2004-02-16
• Last updated: 2012-07-24

Locations

12 sites across 9 countries: Austria, Belgium, France, Germany, Italy, Norway, Portugal, Switzerland, United Kingdom