Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), July 2009

First Received: October 1, 2008 Last Updated: July 7, 2009 History of Changes

Sponsor:	Niigata University Medical and Dental Hospital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00764595

Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumor Metastatic Cancer	Drug: imatinib mesylate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Tumor response [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment:	37
Study Start Date:	October 2008
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of gastrointestinal stromal tumor (GIST)
Hepatic metastasis meeting the following criteria:
- No more than 3 hepatic metastases
- Clinically diagnosed as surgically resectable with no macroscopic residual tumor
- Synchronous hepatic metastasis allowed provided primary tumor is also resectable
No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease
No extrahepatic metastasis
No history of GIST recurrence

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Leukocyte count ≥ 3,000/μL
Neutrophil count ≥ 1,500/μL
Hemoglobin ≥ 8.0 g/dL
Platelet count ≥ 75,000/μL
Total bilirubin ≤ 2.0 mg/dL
ALT and AST < 120 IU/L
GTP < 210 IU/L
Not pregnant
No poorly controlled diabetes mellitus
No NYHA class III-IV cardiac function
No hepatitis B or hepatitis B carriers
No other malignancy requiring treatment

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior imatinib mesylate
No prior interventional radiology for metastatic disease
No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764595

Show 28 Study Locations

Sponsors and Collaborators

Niigata University Medical and Dental Hospital

Investigators

Principal Investigator:

Tatsuo Kanda, MD

Niigata University Medical and Dental Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000615628, NIIGATAU-TRIGIST0805
Study First Received:	October 1, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00764595 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

gastrointestinal stromal tumor
liver metastases

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Neoplastic Processes

Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Neoplasm Metastasis
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

ClinicalTrials.gov processed this record on November 20, 2009