Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
UNICANCER
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00287846
First received: February 6, 2006
Last updated: July 15, 2010
Last verified: December 2006
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Desmoid Tumor |
Drug: imatinib mesylate |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
desmoid tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Non-progression rate at 3 months [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Non-progression rate at 12 months [ Designated as safety issue: No ]
- Toxic effects [ Designated as safety issue: Yes ]
- Tolerance [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Correlation of clinical, biological, and genomic markers with response and long-term stable disease [ Designated as safety issue: No ]
| Estimated Enrollment: | 39 |
| Study Start Date: | August 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287846
Locations
| France | |
| Centre Paul Papin | Recruiting |
| Angers, France, 49036 | |
| Contact: Philippe Maillart 33-2-4135-2700 | |
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Recruiting |
| Besancon, France, 25030 | |
| Contact: Loic Chaigneau 33-81-668-240 | |
| Institut Bergonie | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Nguyen Binh Bui, MD 33-556-333-333 | |
| Centre Regional Francois Baclesse | Recruiting |
| Caen, France, 14076 | |
| Contact: Corinne Delcambre 33-2-3145-5000 | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59020 | |
| Contact: Nicolas Penel, MD 33-3-20-295-920 | |
| Centre Leon Berard | Recruiting |
| Lyon, France, 69373 | |
| Contact: Isabelle Ray-Coquard, MD 33-4-78-78-26-45 | |
| Hopital Edouard Herriot - Lyon | Recruiting |
| Lyon, France, 69437 | |
| Contact: Jean-Yves Blay, MD, PhD 33-47-211-7398 jy.blay@chu-lyon.fr | |
| CHU de la Timone | Recruiting |
| Marseille, France, 13385 | |
| Contact: Florence Duffaud, MD 33-4-9138-5708 fduffaud@mail.ap-hm.fr | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Contact: Didier Cupissol, MD, PhD 33-4-6761-3100 dcupissol@valdorel.fnclcc.fr | |
| CRLCC Nantes - Atlantique | Recruiting |
| Nantes-Saint Herblain, France, 44805 | |
| Contact: Frederic Rolland, MD 33-2-40-67-99-76 F-rolland@nantes.fnclcc.fr | |
| Hopital Tenon | Recruiting |
| Paris, France, 75970 | |
| Contact: Jean-Pierre Lotz, MD 33-1-5601-6058 jean-pierre.lotz@tnn.ap-hop-paris.fr | |
| Institut Curie Hopital | Recruiting |
| Paris, France, 75248 | |
| Contact: Sophie Piperno-Neumann, MD 33-44-32-4000 | |
| Institut Jean Godinot | Recruiting |
| Reims, France, 51056 | |
| Contact: Jean-Christophe Eymard, MD 33-03-2650-4444 jc.eymard@reims.fnclcc.fr | |
| Centre Eugene Marquis | Recruiting |
| Rennes, France, 35042 | |
| Contact: Pierre Kerbrat, MD, PhD 33-299-253-280 kerbrat@rennes.fnclcc.fr | |
| Centre Henri Becquerel | Recruiting |
| Rouen, France, 76038 | |
| Contact: Cecile Guillemet, MD 33-02-32-02-2237 cecile.guillemet@rouen.fnclcc.fr | |
| Centre Rene Huguenin | Recruiting |
| Saint Cloud, France, 92211 | |
| Contact: Michelle Tubiana-Hulin, MD 33-1-47-111-515 | |
| Centre Paul Strauss | Recruiting |
| Strasbourg, France, 67065 | |
| Contact: Patrick R. Dufour, MD 33-388-252-401 pdufour@strasbourg.fnclcc.fr | |
| Hopitaux Universitaire de Strasbourg | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Jean-Pierre Bergerat, MD 33-03-8811-6220 | |
| Hopital Foch | Recruiting |
| Suresnes, France, 92151 | |
| Contact: Laurent Mignot, MD 33-146-252-168 ext. 2288 | |
| Institut Claudius Regaud | Recruiting |
| Toulouse, France, 31052 | |
| Contact: Christine Chevreau-Dalbianco, MD 33-56-142-4114 chevreau.christine@claudiusregaud.fr | |
| Centre Hospitalier Universitaire Bretonneau de Tours | Recruiting |
| Tours, France, 37044 | |
| Contact: Lotfi Benboubker 33-02-4747-3712 | |
| Centre Alexis Vautrin | Recruiting |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Contact: Maria Rios, MD 33-3-8359-8461 m.rios@nancy.fnclcc.fr | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, F-94805 | |
| Contact: Axel Le Cesne, MD 33-1-42-114-316 lecesne@igr.fr | |
Sponsors and Collaborators
UNICANCER
Investigators
| Study Chair: | Jean-Yves Blay, MD, PhD | Hopital Edouard Herriot - Lyon |
More Information
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00287846 History of Changes |
| Other Study ID Numbers: | CDR0000441039, FRE-FNCLCC-SARCOME-05/0401, EU-20515 |
| Study First Received: | February 6, 2006 |
| Last Updated: | July 15, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
desmoid tumor |
Additional relevant MeSH terms:
|
Fibroma Fibromatosis, Aggressive Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013