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Gastrointestinal Stromal TumorPhase 2NCT00041249

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

A Phase 2 study testing brostallicin in people with Gastrointestinal Stromal Tumor and Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor, Sarcoma
What is being tested?
brostallicin
How many people
64 participants
Where
16 sitesin 5 countries
Study dates
May 2002to Jan 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

16 sites in 5 countries.

16 sites in 5 countries

Germany4 sites
  • Robert Roessle Klinik

    Berlin, D-13122

  • Universitaets-Krankenhaus Eppendorf

    Hamburg, D-20246

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

    Munich, D-81377

Other trials in Germany

Netherlands4 sites
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Academisch Ziekenhuis Groningen

    Groningen, 9700 RB

  • Leiden University Medical Center

    Leiden, 2300 RC

  • Daniel Den Hoed Cancer Center at Erasmus University Medical Center

    Rotterdam, 3008 AE

Other trials in Netherlands

France3 sites
  • Centre Leon Berard

    Lyon, 69008

  • CHU de la Timone

    Marseille, 13385

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

United Kingdom3 sites
  • St. James's University Hospital

    Leeds, England, LS9 7TF

  • Royal Marsden NHS Trust - London

    London, England, SW3 6JJ

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

Other trials in United Kingdom

Belgium2 sites
  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
brostallicin
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
Medical subject headings
Gastrointestinal Stromal Tumors, Sarcoma, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Neurofibrosarcoma, Sarcoma, Synovial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brostallicinDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2002
  3. Primary completionJan 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00041249
Sponsor's protocol ID
EORTC-62011
Other IDs
EORTC-62011
Status last verified
Jul 2012
First submitted
8 Jul 2002
Last updated
18 Jul 2012
Results posted
No

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.

    PubMed 17095209
  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brostallicin in people with Gastrointestinal Stromal Tumor and Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany, Netherlands, France, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00041249, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.

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