Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
NCT ID: NCT00287846
Last Updated: 2016-08-30
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
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2004-09-30
2010-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Imatinib
400 to 800 mg/day for a maximal 12 months study duration.
imatinib mesylate
Interventions
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imatinib mesylate
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Jean-Yves Blay, MD, PhD
Role: STUDY_CHAIR
Hopital Edouard Herriot - Lyon
Locations
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Centre Paul Papin
Angers, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Institut Bergonie
Bordeaux, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital Edouard Herriot - Lyon
Lyon, , France
CHU de la Timone
Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Institut Curie Hopital
Paris, , France
Hopital Tenon
Paris, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Huguenin
Saint-Cloud, , France
Centre Paul Strauss
Strasbourg, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Hopital Foch
Suresnes, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
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.
Other Identifiers
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FRE-FNCLCC-SARCOME-05/0401
Identifier Type: -
Identifier Source: secondary_id
EU-20515
Identifier Type: -
Identifier Source: secondary_id
CDR0000441039
Identifier Type: -
Identifier Source: org_study_id
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