Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
NCT ID: NCT00041249
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2002-05-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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brostallicin
Eligibility Criteria
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Exclusion Criteria
* 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
15 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Michael Leahy, MBChB, FRACP, FRCP, FRC Path
Role: STUDY_CHAIR
Fremantle Hospital
Locations
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Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Centre Leon Berard
Lyon, , France
CHU de la Timone
Marseille, , France
Institut Gustave Roussy
Villejuif, , France
Robert Roessle Klinik
Berlin, , Germany
Universitaets-Krankenhaus Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
Munich, , Germany
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, , Netherlands
St. James's University Hospital
Leeds, England, United Kingdom
Royal Marsden NHS Trust - London
London, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Countries
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References
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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.
Other Identifiers
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EORTC-62011
Identifier Type: -
Identifier Source: secondary_id
EORTC-62011
Identifier Type: -
Identifier Source: org_study_id