Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Phase 2

Completed

• Conditions: Gastrointestinal Stromal Tumor

• Registration Number: NCT00112632
• Lead Sponsor: Technical University of Munich

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.

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-06-02
• Study First Submitted QC: 2005-06-02
• Study First Posted: 2005-06-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall tumor response (complete response, partial response, stable disease, and progression of disease)

Secondary Outcome Measures

Name	Time	Method
Time to progression of disease
Overall survival

Trial Locations

Locations (9)

Southwest German Cancer Center at Eberhard-Karls-University; 🇩🇪 Tuebingen, Germany

Universitaetsklinikum Bonn; 🇩🇪 Bonn, Germany

Medizinische Universitaetsklinik I at the University of Cologne; 🇩🇪 Cologne, Germany

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch; 🇩🇪 Berlin, Germany

Allgemeines Krankenhaus - Universitatskliniken; 🇦🇹 Vienna, Austria

University Medical Center Hamburg - Eppendorf; 🇩🇪 Hamburg, Germany

Klinikum der Universitaet Muenchen - Grosshadern Campus; 🇩🇪 Munich, Germany

Klinikum Rechts Der Isar - Technische Universitaet Muenchen; 🇩🇪 Munich, Germany

Dr. Horst-Schmidt-Kliniken; 🇩🇪 Wiesbaden, Germany