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Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00112632
First received: June 2, 2005
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Gastrointestinal Stromal Tumor
Drug: imatinib mesylate
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Overall tumor response (complete response, partial response, stable disease, and progression of disease) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression of disease [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112632

Locations
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
Sponsors and Collaborators
Technische Universität München
Investigators
Study Chair: Thomas Licht, MD Technische Universität München
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00112632     History of Changes
Other Study ID Numbers: CDR0000430499, KRDI-TUM-GIST-CST1571-BDE43, EU-20507
Study First Received: June 2, 2005
Last Updated: March 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
gastrointestinal stromal tumor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014