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Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
exatecan mesylate
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint-Luc
  • U.Z. Gasthuisberg
  • Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
  • Universitatsklinikum Carl Gustav Carl Carus
  • Universitaetsklinikum Essen
  • Universitaets-Krankenhaus Eppendorf
  • Medizinische Hochschule Hannover
  • Eberhard Karls Universitaet
  • National Cancer Institute - Bratislava

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00041236
Brief Title
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
exatecan mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Reichardt, MD
Organizational Affiliation
Robert Roessle Klinik
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carl Carus
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Universitaets-Krankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Eberhard Karls Universitaet
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
National Cancer Institute - Bratislava
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
17336054
Citation
Reichardt P, Nielsen OS, Bauer S, Hartmann JT, Schoffski P, Christensen TB, Pink D, Daugaard S, Marreaud S, Van Glabbeke M, Blay JY; EORTC Soft Tissue and Bone Sarcoma Group. 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. 2007 Apr;43(6):1017-22. doi: 10.1016/j.ejca.2007.01.014. Epub 2007 Mar 1.
Results Reference
result
Citation
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.
Results Reference
result

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Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

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