Working... Menu

Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00041236
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: exatecan mesylate Phase 2

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group
Study Start Date : May 2002
Actual Primary Completion Date : December 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed soft tissue sarcoma

    • Malignant fibrous histiocytoma
    • Liposarcoma
    • Rhabdomyosarcoma
    • Synovial sarcoma
    • Malignant paraganglioma
    • Fibrosarcoma
    • Leiomyosarcoma
    • Angiosarcoma including hemangiopericytoma
    • Malignant peripheral nerve sheath tumor
    • Unclassified sarcoma
    • Miscellaneous sarcoma including mixed mesodermal tumors of the uterus
  • The following tumor types are excluded:

    • Gastrointestinal stromal tumor
    • Chondrosarcoma
    • Malignant mesothelioma
    • Neuroblastoma
    • Osteosarcoma
    • Ewing's sarcoma
    • Embryonal rhabdomyosarcoma
  • Prior chemotherapy for metastatic disease required

    • One line of combination chemotherapy containing anthracycline OR
    • No more than 2 single-agent regimens including anthracycline
    • Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment
  • Must have 1 measurable lesion

    • Clinical evidence of progression within 6 weeks prior to study
    • Osseous lesions and pleural effusions not considered measurable
  • No known or symptomatic CNS metastases



  • 15 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.8 mg/dL
  • Albumin at least 2.5 g/dL


  • Creatinine no greater than 1.4 mg/dL OR
  • Creatinine clearance greater than 65 mL/min


  • No history of severe cardiovascular disease


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 6 months after study participation
  • No other severe medical illness, including psychosis
  • No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • No other concurrent cytotoxic therapy

Endocrine therapy:

  • Not specified


  • No radiotherapy to the sole measurable lesion
  • No concurrent radiotherapy


  • Not specified


  • No other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00041236

Layout table for location information
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, Denmark, DK-8000
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, Germany, D-13122
Universitatsklinikum Carl Gustav Carl Carus
Dresden, Germany, D-01307
Universitaetsklinikum Essen
Essen, Germany, D-45122
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Eberhard Karls Universitaet
Tuebingen, Germany, D-72076
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Layout table for investigator information
Study Chair: Peter Reichardt, MD Robert Roessle Klinik

Publications of Results:
Pink D, Reichardt P, Nielsen OS, et al.: Exatecan (DX-8951f), a new topoisomerase I - inhibitor, is inactive in heavily pretreated patients (pts.) with advanced soft tissue sarcoma (STS): a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group. [Abstract] J Clin Oncol 23 (Suppl 16): A-9058, 830s, 2005.

Layout table for additonal information
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00041236     History of Changes
Other Study ID Numbers: EORTC-62006
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult angiosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult neurofibrosarcoma
adult synovial sarcoma
stage IV adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
adult rhabdomyosarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine leiomyosarcoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic