Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Non-progression rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Non-progression rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Toxic effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: the time between the inclusion date and the progression date ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: the time between the inclusion date and the death whathever the cause ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Correlation of clinical, biological, and genomic markers with response and long-term stable disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||June 2010|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
400 to 800 mg/day for a maximal 12 months study duration.
|Drug: imatinib mesylate|
- Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287846
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Bordeaux, France, 33076|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Hopital Edouard Herriot - Lyon|
|Lyon, France, 69437|
|CHU de la Timone|
|Marseille, France, 13385|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Institut Curie Hopital|
|Paris, France, 75248|
|Paris, France, 75970|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Hopitaux Universitaire de Strasbourg|
|Strasbourg, France, 67091|
|Suresnes, France, 92151|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Jean-Yves Blay, MD, PhD||Hopital Edouard Herriot - Lyon|