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Desmoid TumorPhase 1/2NCT00287846

Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

A Phase 1/2 study testing imatinib mesylate in people with Desmoid Tumor, run by UNICANCER at 23 sites in France.

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 some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Desmoid Tumor
What is being tested?
imatinib mesylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
23 sitesFrance
Study dates
Sep 2004to Jun 2010
Phase
Phase 1/2
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive fibromatosis (desmoid tumor)
  • Relapse or disease progression despite surgery, chemotherapy, radiotherapy, or any other treatment
  • Tumors must meet the following criteria:
  • Ineligible for complete surgical resection by carcinological exeresis OR surgery would cause severe mutilation
  • Cannot be treated with curative radiotherapy
  • Measurable disease by RECIST criteria
  • No prior malignancy

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm^3
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT < 2.5 times ULN
  • Creatinine ≤ 2.5 times normal
  • No severe liver failure
  • No chronic somatic or psychiatric illness that would preclude study compliance
  • No known hypersensitivity to imatinib mesylate or one of its components
  • No geographical, social, or psychological reason that would inhibit follow-up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent immunomodulators*
  • No concurrent hormonal treatments* if used for fibromatosis
  • No concurrent cytotoxic drugs*
  • No concurrent nonsteroidal anti-inflammatory drug* if used for fibromatosis
  • Allowed if used as an analgesic 3 months prior to disease progression
  • No concurrent participation in another therapeutic investigational trial NOTE: *If disease progression has occurred during this treatment, then the treatment must have ended ≥ 1 month prior to study entry

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • CHU de la Timone

    Marseille, 13385

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Tenon

    Paris, 75970

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

  • Hopital Foch

    Suresnes, 92151

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate.

Secondary

  • Determine the non-progression rate in patients after being treated with this drug for 12 months.
  • Determine the toxic effects of this drug in these patients.
  • Determine the tolerance to this drug in these patients.
  • Determine the response rate in patients treated with this drug
  • Determine progression free and overall survival of patients treated with this drug.
  • Determine the quality of life of patients treated with this drug.
  • Correlate clinical, biological, and genomic markers with response and long-term stable disease in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed periodically.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Conditions
Desmoid Tumor
Being tested
imatinib mesylate
Keywords
desmoid tumor
Medical subject headings
Desmoid Tumors

What participants receive

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

  • imatinib mesylateDrug

Study groups in NCT00287846
Study groupRoleWhat they receive
ImatinibExperimental400 to 800 mg/day for a maximal 12 months study duration.
Receives: Drug: imatinib mesylate

What is being measured

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

  1. Non-progression rate

    Measured: 3 months

Secondary outcomes (8)

  1. Non-progression rate

    Measured: 12 months

  2. Toxic effects

    Measured: 12 months

  3. Tolerance

    Measured: 12 months

  4. Response rate

    Measured: 5 years

  5. Progression-free survival

    Measured: the time between the inclusion date and the progression date

  6. Overall survival

    Measured: the time between the inclusion date and the death whathever the cause

  7. Quality of life

    Measured: 5 years

  8. Correlation of clinical, biological, and genomic markers with response and long-term stable disease

    Measured: 5 years

Timeline

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

  1. First posted7 Feb 2006 (estimated)
  2. Study startSep 2004
  3. Primary completionFeb 2006
  4. Study completionJun 2010

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00287846
Sponsor's protocol ID
CDR0000441039
Other IDs
FRE-FNCLCC-SARCOME-05/0401, EU-20515
Status last verified
Aug 2016
First submitted
6 Feb 2006
Last updated
30 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Individual Participant data will not be shared at an individual level.

Publications

  • Penel N, Le Cesne A, Bui BN, Perol D, Brain EG, Ray-Coquard I, Guillemet C, Chevreau C, Cupissol D, Chabaud S, Jimenez M, Duffaud F, Piperno-Neumann S, Mignot L, Blay JY. Imatinib for progressive and recurrent aggressive fibromatosis (desmoid tumors): an FNCLCC/French Sarcoma Group phase II trial with a long-term follow-up. Ann Oncol. 2011 Feb;22(2):452-7. doi: 10.1093/annonc/mdq341. Epub 2010 Jul 9.

    PubMed 20622000

  • Fayette J, Dufresne A, Penel N, et al.: Imatinib for the treatment of aggressive fibromatosis/desmoid tumors (AF/DT) failing local treatment: updated outcome and predictive factors for progression free survival: a FNCLCC French Sarcoma Group-GETO study. [Abstract] J Clin Oncol 25 (Suppl 18): A-10062, 560s, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing imatinib mesylate in people with Desmoid Tumor, run by UNICANCER at 23 sites in France.

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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Non-progression rate (time frame: 3 months). 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 NCT00287846, 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 30 Aug 2016.

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