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Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

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. Identifier: NCT00112632
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : March 8, 2012
Information provided by:
Technische Universität München

Brief Summary:

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor Drug: imatinib mesylate Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:



  • Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate.
  • Determine histological response in patients treated with this drug.


  • Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug.
  • Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection.

After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-alpha
Study Start Date : February 2005

Primary Outcome Measures :
  1. Overall tumor response (complete response, partial response, stable disease, and progression of disease)

Secondary Outcome Measures :
  1. Time to progression of disease
  2. Overall survival

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed gastrointestinal stromal tumor

    • Locally advanced disease
    • Potentially resectable disease*

      • No tumor that can be completely resected (R0) with sufficient margins NOTE: *Multivisceral resection may be necessary
  • Tumor must stain positive for c-Kit (CD117) or platelet-derived growth factor receptor-alpha (PDGFRA) by immunohistochemistry
  • At least 1 site of measurable disease
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-3

Life expectancy

  • Not specified


  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3


  • AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
  • Bilirubin < 1.5 times ULN
  • No chronic active hepatitis
  • No cirrhosis
  • No other chronic liver disease


  • Creatinine < 1.5 times ULN
  • No chronic renal disease


  • No New York Heart Association class III-IV cardiac disease
  • No congestive heart failure
  • No myocardial infarction within the past 6 months


  • No active uncontrolled infection
  • No known HIV positivity


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
  • Must be medically fit to undergo surgery
  • No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention
  • No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention
  • No uncontrolled diabetes
  • No other severe or uncontrolled medical disease
  • No significant history of noncompliance to medical regimens


Biologic therapy

  • No concurrent anticancer biologic agents


  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent systemic corticosteroid therapy unless approved by the study sponsor


  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to ≥ 25% of bone marrow


  • More than 2 weeks since prior major surgery except tumor biopsy


  • More than 4 weeks since prior investigational drugs unless disease is rapidly progressing
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent warfarin for therapeutic anticoagulation

    • Concurrent low molecular weight heparin (e.g., enoxaparin sodium) or heparin for therapeutic anticoagulation allowed
    • Concurrent mini-dose warfarin (e.g.,1 mg/day) for prophylaxis of central venous catheter thrombosis allowed

Information from the National Library of Medicine

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 identifier (NCT number): NCT00112632

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Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria, A-1090
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, Germany, D-13122
Universitaetsklinikum Bonn
Bonn, Germany, D-53105
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany, D-50924
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Southwest German Cancer Center at Eberhard-Karls-University
Tuebingen, Germany, D-72076
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Sponsors and Collaborators
Technische Universität München
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Study Chair: Thomas Licht, MD Technische Universität München
Layout table for additonal information Identifier: NCT00112632    
Other Study ID Numbers: CDR0000430499
First Posted: June 3, 2005    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by Technische Universität München:
gastrointestinal stromal tumor
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action