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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
 (submitted: August 29, 2016)
Non-progression rate [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
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 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 *

*   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  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 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  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