Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00287846 |
Recruitment Status :
Completed
First Posted : February 7, 2006
Last Update Posted : August 30, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
Desmoid Tumor | Drug: imatinib mesylate | Phase 1 Phase 2 |
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 : | Interventional (Clinical Trial) |
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 : | September 2004 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Imatinib
400 to 800 mg/day for a maximal 12 months study duration.
|
Drug: imatinib mesylate |
- Non-progression rate [ Time Frame: 3 months ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287846

Study Chair: | Jean-Yves Blay, MD, PhD | Hopital Edouard Herriot - Lyon |
Responsible Party: | UNICANCER |
ClinicalTrials.gov Identifier: | NCT00287846 |
Other Study ID Numbers: |
CDR0000441039 FRE-FNCLCC-SARCOME-05/0401 EU-20515 |
First Posted: | February 7, 2006 Key Record Dates |
Last Update Posted: | August 30, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Individual Participant data will not be shared at an individual level. |
desmoid tumor |
Fibromatosis, Aggressive Fibroma Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |