Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

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ClinicalTrials.gov Identifier: NCT00287846

Recruitment Status : Completed

First Posted : February 7, 2006

Last Update Posted : August 30, 2016

Sponsor:

Information provided by (Responsible Party):

UNICANCER

Tracking Information

First Submitted Date ^ICMJE

February 6, 2006

First Posted Date ^ICMJE

February 7, 2006

Last Update Posted Date

August 30, 2016

Study Start Date ^ICMJE

September 2004

Actual Primary Completion Date

February 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Non-progression rate [ Time Frame: 3 months ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Non-progression rate [ Time Frame: 12 months ]
Toxic effects [ Time Frame: 12 months ]
Tolerance [ Time Frame: 12 months ]
Response rate [ Time Frame: 5 years ]
Progression-free survival [ Time Frame: the time between the inclusion date and the progression date ]
Overall survival [ Time Frame: the time between the inclusion date and the death whathever the cause ]
Quality of life [ Time Frame: 5 years ]
Correlation of clinical, biological, and genomic markers with response and long-term stable disease [ Time Frame: 5 years ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Desmoid Tumor

Intervention ^ICMJE

Drug: imatinib mesylate

Study Arms ^ICMJE

Experimental: Imatinib

400 to 800 mg/day for a maximal 12 months study duration.

Intervention: Drug: imatinib mesylate

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.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

June 2010

Actual Primary Completion Date

February 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 120 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00287846

Other Study ID Numbers ^ICMJE

CDR0000441039
FRE-FNCLCC-SARCOME-05/0401
EU-20515

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	No
Plan Description:	Individual Participant data will not be shared at an individual level.

Responsible Party

UNICANCER

Study Sponsor ^ICMJE

UNICANCER

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jean-Yves Blay, MD, PhD

Hopital Edouard Herriot - Lyon

PRS Account

UNICANCER

Verification Date

August 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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