Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00287846
First received: February 6, 2006
Last updated: July 15, 2010
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Desmoid Tumor
Drug: imatinib mesylate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Non-progression rate at 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-progression rate at 12 months [ Designated as safety issue: No ]
  • Toxic effects [ Designated as safety issue: Yes ]
  • Tolerance [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Correlation of clinical, biological, and genomic markers with response and long-term stable disease [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287846

Locations
France
Centre Paul Papin Recruiting
Angers, France, 49036
Contact: Philippe Maillart    33-2-4135-2700      
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Loic Chaigneau    33-81-668-240      
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Nguyen Binh Bui, MD    33-556-333-333      
Centre Regional Francois Baclesse Recruiting
Caen, France, 14076
Contact: Corinne Delcambre    33-2-3145-5000      
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Nicolas Penel, MD    33-3-20-295-920      
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Isabelle Ray-Coquard, MD    33-4-78-78-26-45      
Hopital Edouard Herriot - Lyon Recruiting
Lyon, France, 69437
Contact: Jean-Yves Blay, MD, PhD    33-47-211-7398    jy.blay@chu-lyon.fr   
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Florence Duffaud, MD    33-4-9138-5708    fduffaud@mail.ap-hm.fr   
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Didier Cupissol, MD, PhD    33-4-6761-3100    dcupissol@valdorel.fnclcc.fr   
CRLCC Nantes - Atlantique Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Frederic Rolland, MD    33-2-40-67-99-76    F-rolland@nantes.fnclcc.fr   
Institut Curie Hopital Recruiting
Paris, France, 75248
Contact: Sophie Piperno-Neumann, MD    33-44-32-4000      
Hopital Tenon Recruiting
Paris, France, 75970
Contact: Jean-Pierre Lotz, MD    33-1-5601-6058    jean-pierre.lotz@tnn.ap-hop-paris.fr   
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Jean-Christophe Eymard, MD    33-03-2650-4444    jc.eymard@reims.fnclcc.fr   
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Contact: Pierre Kerbrat, MD, PhD    33-299-253-280    kerbrat@rennes.fnclcc.fr   
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Cecile Guillemet, MD    33-02-32-02-2237    cecile.guillemet@rouen.fnclcc.fr   
Centre Rene Huguenin Recruiting
Saint Cloud, France, 92211
Contact: Michelle Tubiana-Hulin, MD    33-1-47-111-515      
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Patrick R. Dufour, MD    33-388-252-401    pdufour@strasbourg.fnclcc.fr   
Hopitaux Universitaire de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Jean-Pierre Bergerat, MD    33-03-8811-6220      
Hopital Foch Recruiting
Suresnes, France, 92151
Contact: Laurent Mignot, MD    33-146-252-168 ext. 2288      
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Christine Chevreau-Dalbianco, MD    33-56-142-4114    chevreau.christine@claudiusregaud.fr   
Centre Hospitalier Universitaire Bretonneau de Tours Recruiting
Tours, France, 37044
Contact: Lotfi Benboubker    33-02-4747-3712      
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Maria Rios, MD    33-3-8359-8461    m.rios@nancy.fnclcc.fr   
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Axel Le Cesne, MD    33-1-42-114-316    lecesne@igr.fr   
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Jean-Yves Blay, MD, PhD Hopital Edouard Herriot - Lyon
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00287846     History of Changes
Other Study ID Numbers: CDR0000441039, FRE-FNCLCC-SARCOME-05/0401, EU-20515
Study First Received: February 6, 2006
Last Updated: July 15, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
desmoid tumor

Additional relevant MeSH terms:
Fibromatosis, Aggressive
Fibroma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014