- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112632
Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Vienna, Austria, A-1090
- Allgemeines Krankenhaus - Universitatskliniken
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-
-
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Berlin, Germany, D-13122
- Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
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Bonn, Germany, D-53105
- Universitaetsklinikum Bonn
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Cologne, Germany, D-50924
- Medizinische Universitaetsklinik I at the University of Cologne
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Hamburg, Germany, D-20246
- University Medical Center Hamburg - Eppendorf
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Munich, Germany, D-81377
- Klinikum der Universitaet Muenchen - Grosshadern Campus
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Munich, Germany, D-81675
- Klinikum Rechts der Isar - Technische Universitaet Muenchen
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Tuebingen, Germany, D-72076
- Southwest German Cancer Center at Eberhard-Karls-University
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Wiesbaden, Germany, D-65199
- Dr. Horst-Schmidt-Kliniken
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Platelet count > 100,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
Hepatic
- 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
Renal
- Creatinine < 1.5 times ULN
- No chronic renal disease
Cardiovascular
- No New York Heart Association class III-IV cardiac disease
- No congestive heart failure
- No myocardial infarction within the past 6 months
Immunology
- No active uncontrolled infection
- No known HIV positivity
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent anticancer biologic agents
Chemotherapy
- 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
Radiotherapy
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to ≥ 25% of bone marrow
Surgery
- More than 2 weeks since prior major surgery except tumor biopsy
Other
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Overall tumor response (complete response, partial response, stable disease, and progression of disease)
|
Secondary Outcome Measures
Outcome Measure |
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Overall survival
|
Time to progression of disease
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thomas Licht, MD, Technical University of Munich
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neoplasms, Connective Tissue
- Gastrointestinal Stromal Tumors
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- CDR0000430499
- KRDI-TUM-GIST-CST1571-BDE43
- EU-20507
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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