Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

NCT00112632 | Completed Phase 2

• 3 other identifiers: CDR0000430499KRDI-TUM-GIST-CST1571-BDE43EU-20507
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 9

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.

Conditions

Gastrointestinal Stromal Tumor

Keywords

gastrointestinal stromal tumor

Outcome Measures

Primary Outcomes (1)

• Overall tumor response (complete response, partial response, stable disease, and progression of disease)

Secondary Outcomes (2)

• Time to progression of disease

• Overall survival

Interventions

imatinib mesylate DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (9)

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

Location

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

Berlin, D-13122, Germany

Location

Universitaetsklinikum Bonn

Bonn, D-53105, Germany

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Combined Modality Therapy; Therapeutics

Study Officials

• Thomas Licht, MD

  Technical University of Munich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: February 1, 2005
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

DE (8); AU (1)