NCT00287846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

February 6, 2006

Last Update Submit

August 29, 2016

Conditions

Desmoid Tumor

Keywords

desmoid tumor

Outcome Measures

Primary Outcomes (1)

  • Non-progression rate

    3 months

Secondary Outcomes (8)

  • Non-progression rate

    12 months

  • Toxic effects

    12 months

  • Tolerance

    12 months

  • Response rate

    5 years

  • Progression-free survival

    the time between the inclusion date and the progression date

  • +3 more secondary outcomes

Study Arms (1)

Imatinib

EXPERIMENTAL

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

Drug: imatinib mesylate

Interventions

imatinib mesylateDRUG
Imatinib

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (23)

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Tenon

Paris, 75970, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (2)

  • 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.

    PMID: 20622000RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Jean-Yves Blay, MD, PhD

    Hopital Edouard Herriot - Lyon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

September 1, 2004

Primary Completion

February 1, 2006

Study Completion

June 1, 2010

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Individual Participant data will not be shared at an individual level.

Locations

FR(23)