Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

Phase 2

Completed

• Conditions: Sarcoma

• Registration Number: NCT00041236
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 exatecan mesylate in treating patients who have advanced soft tissue sarcoma.

Detailed Description

OBJECTIVES:

* Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.

* Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).

Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.

PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-07-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade; 🇩🇰 Aarhus, Denmark

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch; 🇩🇪 Berlin, Germany

Universitatsklinikum Carl Gustav Carl Carus; 🇩🇪 Dresden, Germany

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

Universitaets-Krankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Eberhard Karls Universitaet; 🇩🇪 Tuebingen, Germany

National Cancer Institute - Bratislava; 🇸🇰 Bratislava, Slovakia