Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 15 to 75 Other EORTC-62006 NCT00041236

Objectives

1. Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
2. Determine the safety of this drug in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 15 to 75

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Reichardt P, Nielsen OS, Bauer S, et al.: Exatecan in pretreated adult patients with advanced soft tissue sarcoma: results of a phase II--study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer 43 (6): 1017-22, 2007.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Peter Reichardt, MD, Study coordinator		Ph: 49-304-5055-3893 Email: reichardt@rrk-berlin.de

Registry Information
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
Trial Start Date		2002-05-15
Registered in ClinicalTrials.gov		NCT00041236
Date Submitted to PDQ		2002-05-28
Information Last Verified		2005-02-23

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