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STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006357
  Purpose

RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective treatment for soft tissue sarcoma.

PURPOSE: Phase I/II trial to study the effectiveness of STI571 in treating patients who have recurrent or refractory soft tissue sarcoma.


Condition Intervention Phase
Endometrial Cancer
Gastrointestinal Stromal Tumor
Ovarian Cancer
Sarcoma
Small Intestine Cancer
Drug: imatinib mesylate
Phase I
Phase II

MedlinePlus related topics:   Cancer    Intestinal Cancer    Ovarian Cancer    Soft Tissue Sarcoma   

ChemIDplus related topics:   Imatinib    Imatinib mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Dose Finding and Phase II Study of STI 571 in Advanced Soft Tissue Sarcoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 2000

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose and associated toxicity of STI571 in patients with refractory or recurrent soft tissue sarcoma. II. Determine the pharmacokinetic profile of this treatment regimen in these patients. III. Determine the objective response and duration of response in these patients with this treatment regimen.

OUTLINE: This is a dose escalation and dose efficacy, multicenter study. In the dose efficacy portion, patients are stratified according to disease type (gastrointestinal stromal tumor vs all other soft tissue sarcomas). Phase I: Patients receive oral STI571 daily for a maximum of 24 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6-8 patients experience dose limiting toxicities. The recommended phase II dose is defined as the dose preceding the MTD. Phase II: Patients receive the recommended phase II dose of STI571 as in phase I. Patients are followed every 8 weeks until disease progression, and then every 16 weeks thereafter.

PROJECTED ACCRUAL: Approximately 47-72 patients (7-32 in phase I and 40 in phase II) will be accrued for this study.

  Eligibility
Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma Hemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus) Gastrointestinal stromal tumor (GIST) (must be c-kit positive) No malignant mesothelioma, chondrosarcoma, neuroblastoma, osteosarcoma, Ewing's sarcoma, or embryonal rhabdomyosarcoma Phase I study and nonGIST phase II study patients: Must have received one prior first line combination chemotherapy regimen or two first line single agent regimens Adjuvant chemotherapy not considered first line, unless disease progression within 6 months of treatment Phase II GIST patients: No more than one prior first line combination chemotherapy regimen or two first line single agent regimens Adjuvant chemotherapy not considered first line, unless disease progression within 6 months of treatment Measurable disease with evidence of progression in past 6 weeks Osseous lesions and pleural effusions not considered measurable No symptomatic or known CNS metastases

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Albumin at least 25 g/L Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance greater than 65 mL/min Cardiovascular: No history of cardiovascular disease Other: No prior or concurrent second primary malignant tumors except adequately treated carcinoma in situ of the cervix or basal cell carcinoma No other severe illness (including psychosis) Not pregnant Fertile patients must use effective contraception during and for 6 months following study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent local or systemic chemotherapy Endocrine therapy: No concurrent systemic corticosteroid therapy Radiotherapy: No prior radiotherapy to sole index lesion Concurrent radiotherapy to any lesion allowed if not the sole target lesion Surgery: Not specified Other: No prior embolization to sole index lesion No other concurrent investigational drug No concurrent warfarin

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006357

Locations
Belgium
U.Z. Gasthuisberg    
      Leuven, Belgium, B-3000
Universitair Ziekenhuis Antwerpen    
      Edegem, Belgium, B-2650
Denmark
Aarhus Kommunehospital    
      Aarhus, Denmark, DK-8000
Herlev Hospital - University Hospital of Copenhagen    
      Herlev, Denmark, DK-2730
Rigshospitalet    
      Copenhagen, Denmark, 2100
France
Centre Leon Berard    
      Lyon, France, 69373
Institut Gustave Roussy    
      Villejuif, France, F-94805
Netherlands
Academisch Ziekenhuis Groningen    
      Groningen, Netherlands, 9713 EZ
Antoni van Leeuwenhoekhuis    
      Amsterdam, Netherlands, 1066 CX
Leiden University Medical Center    
      Leiden, Netherlands, 2300 CA
Rotterdam Cancer Institute    
      Rotterdam, Netherlands, 3075 EA
University Medical Center Nijmegen    
      Nijmegen, Netherlands, NL-6252 HB
United Kingdom, England
Weston Park Hospital    
      Sheffield, England, United Kingdom, S1O 2SJ
Nottingham City Hospital NHS Trust    
      Nottingham, England, United Kingdom, NG5 1PB
Royal Marsden NHS Trust    
      London, England, United Kingdom, SW3 6JJ
Christie Hospital N.H.S. Trust    
      Manchester, England, United Kingdom, M20 4BX

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Jacob Verweij, MD, PhD     Daniel Den Hoed Cancer Center at Erasmus Medical Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Debiec-Rychter M, Dumez H, Judson I, Wasag B, Verweij J, Brown M, Dimitrijevic S, Sciot R, Stul M, Vranck H, Scurr M, Hagemeijer A, van Glabbeke M, van Oosterom AT; EORTC Soft Tissue and Bone Sarcoma Group. Use of c-KIT/PDGFRA mutational analysis to predict the clinical response to imatinib in patients with advanced gastrointestinal stromal tumours entered on phase I and II studies of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2004 Mar;40(5):689-95.
 
Verweij J, van Oosterom A, Blay JY, Judson I, Rodenhuis S, van der Graaf W, Radford J, Le Cesne A, Hogendoorn PC, di Paola ED, Brown M, Nielsen OS. Imatinib mesylate (STI-571 Glivec, Gleevec) is an active agent for gastrointestinal stromal tumours, but does not yield responses in other soft-tissue sarcomas that are unselected for a molecular target. Results from an EORTC Soft Tissue and Bone Sarcoma Group phase II study. Eur J Cancer. 2003 Sep;39(14):2006-11.
 
van Oosterom AT, Judson IR, Verweij J, Stroobants S, Dumez H, Donato di Paola E, Sciot R, Van Glabbeke M, Dimitrijevic S, Nielsen OS; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Update of phase I study of imatinib (STI571) in advanced soft tissue sarcomas and gastrointestinal stromal tumors: a report of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2002 Sep;38 Suppl 5:S83-7.
 
van Oosterom AT, Judson I, Verweij J, Stroobants S, Donato di Paola E, Dimitrijevic S, Martens M, Webb A, Sciot R, Van Glabbeke M, Silberman S, Nielsen OS; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study. Lancet. 2001 Oct 27;358(9291):1421-3.
 

Study ID Numbers:   CDR0000068226, EORTC-62001, EORTC-16003, NOVARTIS-CSTI5710203
First Received:   October 4, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006357
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult angiosarcoma  
adult fibrosarcoma  
adult leiomyosarcoma  
adult liposarcoma  
adult neurofibrosarcoma  
adult synovial sarcoma  
recurrent adult soft tissue sarcoma  
small intestine leiomyosarcoma  
adult alveolar soft-part sarcoma  
adult epithelioid sarcoma  
adult malignant fibrous histiocytoma  
adult malignant hemangiopericytoma
adult malignant mesenchymoma
adult rhabdomyosarcoma
ovarian stromal cancer
recurrent uterine sarcoma
uterine carcinosarcoma
uterine leiomyosarcoma
endometrial stromal sarcoma
ovarian sarcoma
gastrointestinal stromal tumor

Study placed in the following topic categories:
Sarcoma, Endometrial Stromal
Fibrosarcoma
Histiocytoma, Benign Fibrous
Malignant mesenchymal tumor
Urogenital Neoplasms
Duodenal Neoplasms
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Endometrial Neoplasms
Sarcoma, Alveolar Soft Part
Endocrine Gland Neoplasms
Rhabdomyosarcoma
Digestive System Neoplasms
Endometrial stromal sarcoma
Synovial sarcoma
Genital Neoplasms, Female
Endocrine System Diseases
Hemangiopericytoma
Imatinib
Liposarcoma
Histiocytoma
Sarcoma
Gastrointestinal Neoplasms
Uterine sarcoma
Histiocytoma, Malignant Fibrous
Leiomyosarcoma
Gonadal Disorders
Gastrointestinal Diseases
Epithelioid sarcoma
Alveolar soft part sarcoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Jejunal Diseases
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Ileal Diseases
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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