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Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

Primary Purpose

Gastrointestinal Stromal Tumor, Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
brostallicin
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 Gastrointestinal Stromal Tumor focused on measuring adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult rhabdomyosarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma

Eligibility Criteria

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

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

Sites / Locations

  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Centre Leon Berard
  • CHU de la Timone
  • Institut Gustave Roussy
  • Robert Roessle Klinik
  • Universitaets-Krankenhaus Eppendorf
  • Medizinische Hochschule Hannover
  • Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Academisch Ziekenhuis Groningen
  • Leiden University Medical Center
  • Daniel Den Hoed Cancer Center at Erasmus University Medical Center
  • St. James's University Hospital
  • Royal Marsden NHS Trust - London
  • Northern Centre for Cancer Treatment at Newcastle General Hospital

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
NCT00041249
Brief Title
Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Official Title
Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
January 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 brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor, Sarcoma
Keywords
adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult rhabdomyosarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
brostallicin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Leahy, MBChB, FRACP, FRCP, FRC Path
Organizational Affiliation
Fremantle Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Robert Roessle Klinik
City
Berlin
ZIP/Postal Code
D-13122
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
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17095209
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

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