- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00041249
Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the antitumor activity of brostallicin, in terms of objective response, in patients with locally advanced or metastatic soft tissue sarcoma who have failed one prior chemotherapy treatment.
- Determine the time to progression and duration of response in patients treated with this drug.
- Determine the safety and toxic effects of this drug in these patients.
- Correlate clinical outcome with whole blood glutathione level in patients treated with this drug.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Lyon, France, 69008
- Centre Léon Bérard
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Marseille, France, 13385
- CHU de la Timone
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Villejuif, France, F-94805
- Institut Gustave Roussy
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Berlin, Germany, D-13122
- Robert Roessle Klinik
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Hamburg, Germany, D-20246
- Universitaets-Krankenhaus Eppendorf
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Hannover, Germany, D-30625
- Medizinische Hochschule Hannover
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Munich, Germany, D-81377
- Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
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Amsterdam, Netherlands, 1066 CX
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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Groningen, Netherlands, 9700 RB
- Academisch Ziekenhuis Groningen
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Leiden, Netherlands, 2300 RC
- Leiden University Medical Center
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Rotterdam, Netherlands, 3008 AE
- Daniel Den Hoed Cancer Center at Erasmus University Medical Center
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England
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Leeds, England, United Kingdom, LS9 7TF
- St. James's University Hospital
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London, England, United Kingdom, SW3 6JJ
- Royal Marsden NHS Trust - London
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Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
- Northern Centre for Cancer Treatment at Newcastle General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
Stratum I
- Malignant fibrous histiocytoma
- Liposarcoma
- Rhabdomyosarcoma
- Synovial sarcoma
- Malignant paraganglioma
- Fibrosarcoma
- Leiomyosarcoma
- Angiosarcoma including hemangiopericytoma
- Malignant peripheral nerve sheath tumor
- Unclassified sarcoma
- Miscellaneous sarcoma
Stratum II
- Gastrointestinal stromal tumor
- Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression
The following sarcoma types are excluded:
- Mixed mesodermal tumors of the uterus (and carcinosarcoma)
- Chondrosarcoma
- Malignant mesothelioma
- Neuroblastoma
- Osteosarcoma
- Ewing's sarcoma
- Embryonal rhabdomyosarcoma
- 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:
- Over 15
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 1.25 times upper limit of normal (ULN)
- SGPT and SGOT no greater than 3 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.4 mg/dL OR
- Creatinine clearance greater than 65 mL/min
Cardiovascular:
- No prior severe cardiovascular disease
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 6 months after study
- No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- No other severe medical illness
- No psychosis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic response modifiers or immunotherapy
- No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF)
Chemotherapy:
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy and recovered
- Prior adjuvant chemotherapy as first-line treatment allowed provided disease progressed within 6 months after the completion of chemotherapy
- No prior ecteinascidin 743 (stratum I)
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
Radiotherapy:
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to sole measurable lesion
- Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's discretion
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- No other concurrent anticancer therapy (approved or investigational)
- No concurrent participation in any other clinical treatment study
- No other concurrent investigational drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Michael Leahy, MBChB, FRACP, FRCP, FRC Path, Fremantle Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
- gastrointestinal stromal tumor
- stage III adult soft tissue sarcoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-62011
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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