Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
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ClinicalTrials.gov Identifier: NCT00112632 |
Recruitment Status
:
Completed
First Posted
: June 3, 2005
Last Update Posted
: March 8, 2012
|
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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 |
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 : | 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 |

- Overall tumor response (complete response, partial response, stable disease, and progression of disease)
- Time to progression of disease
- Overall survival

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

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): NCT00112632
Austria | |
Allgemeines Krankenhaus - Universitatskliniken | |
Vienna, Austria, A-1090 | |
Germany | |
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 |
Study Chair: | Thomas Licht, MD | Technische Universität München |
ClinicalTrials.gov Identifier: | NCT00112632 History of Changes |
Other Study ID Numbers: |
CDR0000430499 KRDI-TUM-GIST-CST1571-BDE43 EU-20507 |
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:
Gastrointestinal Stromal Tumors Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |