Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

July 17, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Aarhus, Denmark, DK-8000
        • Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
  • Germany
      • Berlin, Germany, D-13122
        • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
      • Dresden, Germany, D-01307
        • Universitatsklinikum Carl Gustav Carl Carus
      • Essen, Germany, D-45122
        • Universitaetsklinikum Essen
      • Hamburg, Germany, D-20246
        • Universitaets-Krankenhaus Eppendorf
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover
      • Tuebingen, Germany, D-72076
        • Eberhard Karls Universitaet
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • National Cancer Institute - Bratislava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 15 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

  • No history of severe cardiovascular disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • Not specified

Other:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Peter Reichardt, MD, Robert Roessle Klinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

July 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-62006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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