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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2006

Last Updated Date

July 15, 2010

Start Date ^ICMJE

August 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Non-progression rate at 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 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 ]

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

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Desmoid Tumor

Intervention ^ICMJE

Drug: imatinib mesylate

Study Arm (s)

Not Provided

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.

* 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

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

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 and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00287846

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UNICANCER

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jean-Yves Blay, MD, PhD

Hopital Edouard Herriot - Lyon

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2006

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

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