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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-62011 |
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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 brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to tumor (tumors other than gastrointestinal stromal tumor (GIST) vs GIST).
Patients receive brostallicin IV over 10 minutes on day 1. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 1 year.
PROJECTED ACCRUAL: A total of 58-72 patients (40 for stratum I and 18-32 for stratum II) will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brostallicin | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
Stratum I
Stratum II
The following sarcoma types are excluded:
At least one measurable lesion
Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease
Clinical evidence of progression within 6 weeks prior to study treatment
No known or symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Leahy, MBChB, FRACP, FRCP, FRC Path | Fremantle Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium | |||
| U.Z. Gasthuisberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17095209 | Result | Leahy M, Ray-Coquard I, Verweij J, Le Cesne A, Duffaud F, Hogendoorn PC, Fowst C, de Balincourt C, di Paola ED, van Glabbeke M, Judson I, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Brostallicin, an agent with potential activity in metastatic soft tissue sarcoma: a phase II study from the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Jan;43(2):308-15. doi: 10.1016/j.ejca.2006.09.014. Epub 2006 Nov 13. | |
| Result | Leahy MG, Blay JY, Verweij J, et al.: EORTC 62011: phase II trial of brostallicin for soft tissue sarcoma. [Abstract] Eur J Cancer Suppl 1 (5): S209, A-694, 2003. |
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| Leuven |
| B-3000 |
| Belgium |
| Centre Leon Berard | Lyon | 69008 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| Robert Roessle Klinik | Berlin | D-13122 | Germany |
| Universitaets-Krankenhaus Eppendorf | Hamburg | D-20246 | Germany |
| Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
| Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen | Munich | D-81377 | Germany |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | 1066 CX | Netherlands |
| Academisch Ziekenhuis Groningen | Groningen | 9700 RB | Netherlands |
| Leiden University Medical Center | Leiden | 2300 RC | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus University Medical Center | Rotterdam | 3008 AE | Netherlands |
| St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Royal Marsden NHS Trust - London | London | England | SW3 6JJ | United Kingdom |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle upon Tyne | England | NE4 6BE | United Kingdom |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D012509 | Sarcoma |
| D006394 | Hemangiosarcoma |
| D005354 | Fibrosarcoma |
| D007890 | Leiomyosarcoma |
| D008080 | Liposarcoma |
| D018319 | Neurofibrosarcoma |
| D013584 | Sarcoma, Synovial |
| D051677 | Histiocytoma, Malignant Fibrous |
| C562740 | Hemangiopericytoma, Malignant |
| D012208 | Rhabdomyosarcoma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009383 | Neoplasms, Vascular Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D009379 | Neoplasms, Muscle Tissue |
| D018205 | Neoplasms, Adipose Tissue |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D051642 | Histiocytoma |
| D009217 | Myosarcoma |
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| ID | Term |
|---|---|
| C455279 | brostallicin |
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