Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis - Full Text View

Sponsor:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00287846

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 I Phase II

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:

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

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

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
Hopital Tenon	Recruiting
Paris, France, 75970
Contact: Jean-Pierre Lotz, MD 33-1-5601-6058 jean-pierre.lotz@tnn.ap-hop-paris.fr
Institut Curie Hopital	Recruiting
Paris, France, 75248
Contact: Sophie Piperno-Neumann, MD 33-44-32-4000
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

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Jean-Yves Blay, MD, PhD

Hopital Edouard Herriot - Lyon

More Information

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. 2010 Jul 9; [Epub ahead of print]

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:

Fibroma
Fibromatosis, Aggressive
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012