Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Desmoid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287846
• Other study ID #: CDR0000441039
• Secondary ID: FRE-FNCLCC-SARCO
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 6, 2006
• Last updated: August 29, 2016
• Start date: September 2004
• Est. completion date: June 2010

Study information

• Verified date: August 2016
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Desmoid Tumor
• Fibroma

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon
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	Hopital Tenon	Paris
France	Institut Curie Hopital	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	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (2)

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. [

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-progression rate		3 months	No
Secondary	Non-progression rate		12 months	No
Secondary	Toxic effects		12 months	Yes
Secondary	Tolerance		12 months	Yes
Secondary	Response rate		5 years	No
Secondary	Progression-free survival		the time between the inclusion date and the progression date	No
Secondary	Overall survival		the time between the inclusion date and the death whathever the cause	No
Secondary	Quality of life		5 years	No
Secondary	Correlation of clinical, biological, and genomic markers with response and long-term stable disease		5 years	No