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Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Sponsor
UNICANCER (Other)
Overall Status
Completed
CT.gov ID
NCT00287846
Collaborator
(none)
40
Enrollment
23
Locations
1
Arm
69
Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: imatinib mesylate
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Feb 1, 2006
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Imatinib

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

Drug: imatinib mesylate

Outcome Measures

Primary Outcome Measures

  1. Non-progression rate [3 months]

Secondary Outcome Measures

  1. Non-progression rate [12 months]

  2. Toxic effects [12 months]

  3. Tolerance [12 months]

  4. Response rate [5 years]

  5. Progression-free survival [the time between the inclusion date and the progression date]

  6. Overall survival [the time between the inclusion date and the death whathever the cause]

  7. Quality of life [5 years]

  8. Correlation of clinical, biological, and genomic markers with response and long-term stable disease [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Paul Papin Angers France 49036
2 Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Besancon France 25030
3 Institut Bergonie Bordeaux France 33076
4 Centre Regional Francois Baclesse Caen France 14076
5 Centre Oscar Lambret Lille France 59020
6 Centre Leon Berard Lyon France 69373
7 Hopital Edouard Herriot - Lyon Lyon France 69437
8 CHU de la Timone Marseille France 13385
9 Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Montpellier France 34298
10 CRLCC Nantes - Atlantique Nantes-Saint Herblain France 44805
11 Institut Curie Hopital Paris France 75248
12 Hopital Tenon Paris France 75970
13 Institut Jean Godinot Reims France 51056
14 Centre Eugene Marquis Rennes France 35042
15 Centre Henri Becquerel Rouen France 76038
16 Centre Rene Huguenin Saint Cloud France 92211
17 Centre Paul Strauss Strasbourg France 67065
18 Hopitaux Universitaire de Strasbourg Strasbourg France 67091
19 Hopital Foch Suresnes France 92151
20 Institut Claudius Regaud Toulouse France 31052
21 Centre Hospitalier Universitaire Bretonneau de Tours Tours France 37044
22 Centre Alexis Vautrin Vandoeuvre-les-Nancy France 54511
23 Institut Gustave Roussy Villejuif France F-94805

Sponsors and Collaborators

  • UNICANCER

Investigators

  • Study Chair: Jean-Yves Blay, MD, PhD, Hopital Edouard Herriot - Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
UNICANCER
ClinicalTrials.gov Identifier:
NCT00287846
Other Study ID Numbers:
  • CDR0000441039
  • FRE-FNCLCC-SARCOME-05/0401
  • EU-20515
First Posted:
Feb 7, 2006
Last Update Posted:
Aug 30, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by UNICANCER
desmoid tumor
Additional relevant MeSH terms:
Fibromatosis, Aggressive
Fibroma
Imatinib Mesylate

Study Results

No Results Posted as of Aug 30, 2016