Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

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; (submitted: August 29, 2016)	Non-progression rate [ Time Frame: 3 months ]
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; (submitted: August 29, 2016)	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 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	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Desmoid Tumor
Intervention ICMJE	Drug: imatinib mesylate
Study Arms	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; (submitted: August 29, 2016)	40
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	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	Sexes Eligible for Study: All
Ages	18 Years to 120 Years (Adult, Senior)
Accepts Healthy Volunteers	No
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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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