Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00041236
First received: July 8, 2002
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Sarcoma
Drug: exatecan mesylate
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 39
Study Start Date: May 2002
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041236

Locations
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Denmark
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, Denmark, DK-8000
Germany
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
Slovakia
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Peter Reichardt, MD Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
  More Information

Additional Information:
Publications:
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.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00041236     History of Changes
Other Study ID Numbers: EORTC-62006, EORTC-62006
Study First Received: July 8, 2002
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

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:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Exatecan
Camptothecin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014