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SarcomaPhase 2NCT00085475

Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma

A Phase 2 study testing imatinib mesylate and conventional surgery in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 7 sites in 4 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: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
imatinib mesylate and conventional surgery
Type of treatment
Surgery or procedure
How many people
17 participants
Where
7 sitesin 4 countries
Study dates
Apr 2004to Apr 2007
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma
  • Locally advanced or metastatic disease
  • Measurable disease
  • Not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
  • Documented progressive disease within the past 3 months
  • Previously irradiated lesions must show disease progression
  • Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization
  • Translocation t(17;22)(q22;q13)
  • No prior chemotherapy OR previously treated with 1, and only 1, line of combination chemotherapy with ifosfamide and doxorubicin OR 2 lines of single-agent therapy OR relapsed within 6 months after adjuvant chemotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 mg/dL* NOTE: *Transfusion allowed

Hepatic

  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
  • Bilirubin ≤ 1.5 times ULN
  • No uncontrolled hepatic disease

Renal

  • Creatinine ≤ 1.5 times ULN
  • No uncontrolled renal disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No uncontrolled diabetes
  • No active or uncontrolled infection
  • No concurrent severe or uncontrolled medical disease
  • No medical, psychological, familial, sociological, or geographical condition that would preclude study participation, compliance, or giving informed consent
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 28 days since prior biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent anticancer biologic agents

Chemotherapy

  • See Disease Characteristics
  • More than 28 days since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • No concurrent radiotherapy
  • Concurrent palliative radiotherapy allowed provided radiotherapy will not be administered to a target lesion

Surgery

  • Not specified

Other

  • More than 28 days since prior investigational drugs
  • No concurrent therapeutic anticoagulation therapy with warfarin
  • Concurrent low-molecular weight heparin or mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs
  • No other concurrent cytostatic agents
  • No other concurrent tyrosine kinase inhibitors

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

Belgium2 sites
  • Institut Jules Bordet

    Brussels, 1000

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

France2 sites
  • Institut Bergonie

    Bordeaux, 33076

  • CHU de la Timone

    Marseille, 13385

Other trials in France

Netherlands2 sites
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Leiden University Medical Center

    Leiden, 2300 CA

Other trials in Netherlands

United Kingdom1 site
  • Christie Hospital NHS Trust

    Manchester, England, M20 4BX

Other trials in United Kingdom

About this study

Official title: Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.
  • Determine the progression-free rate at 14 weeks in patients treated with this drug.

Secondary

  • Determine objective response rate, progression-free survival, and overall survival in patients treated with this drug.
  • Determine the duration of response in patients treated with this drug.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks. Patients with a partial or complete response at 14 weeks undergo surgical resection if possible. If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved (section margins positive), patients continue to receive imatinib mesylate in the absence of disease progression

Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2 years.

Conditions
Sarcoma
Being tested
imatinib mesylate, conventional surgery
Keywords
recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, adult fibrosarcoma, adult malignant fibrous histiocytoma
Medical subject headings
Sarcoma, Fibrosarcoma, Histiocytoma, Malignant Fibrous

What participants receive

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free rate at 14 weeks

Secondary outcomes (5)
  1. Response rate as assessed by RECIST criteria

  2. Progression-free survival

  3. Overall survival

  4. Duration of response

  5. Toxicity as assessed by CTC 3.0

Timeline

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

  1. First posted11 Jun 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionApr 2007

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
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00085475
Sponsor's protocol ID
EORTC-62027
Other IDs
EORTC-62027, EUDRACT-2004-002538-20
Status last verified
Sep 2012
First submitted
10 Jun 2004
Last updated
24 Sep 2012
Results posted
No

Publications

  • Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM; European Organisation for Research and Treatment of Cancer Soft Tissue/Bone Sarcoma Group; Southwest Oncology Group. Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol. 2010 Apr 1;28(10):1772-9. doi: 10.1200/JCO.2009.25.7899. Epub 2010 Mar 1.

    PubMed 20194851

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate and conventional surgery in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 7 sites in 4 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 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Belgium, France, Netherlands, United Kingdom. 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.

What does the primary outcome measure?

Progression-free rate at 14 weeks. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00085475, which also lists 1 linked publication.

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 24 Sep 2012.

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