Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UNICANCER

ClinicalTrials.gov Identifier:

NCT00287846

First received: February 6, 2006

Last updated: August 29, 2016

Last verified: August 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2006

Last Updated Date

August 29, 2016

Start Date ^ICMJE

September 2004

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00287846 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Non-progression rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Toxic effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: the time between the inclusion date and the progression date ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: the time between the inclusion date and the death whathever the cause ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Correlation of clinical, biological, and genomic markers with response and long-term stable disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Desmoid Tumor

Intervention ^ICMJE

Drug: imatinib mesylate

Study Arm (s)

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

Enrollment ^ICMJE

Completion Date

June 2010

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

Gender

Both

Ages

18 Years to 120 Years (Adult, Senior)

Accepts Healthy Volunteers

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

Plan to Share Data

IPD 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

Information Provided By

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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