This trial is active, not recruiting.

Conditions gastrointestinal stromal tumor, metastatic cancer
Treatment imatinib mesylate
Phase phase 2
Sponsor Niigata University Medical and Dental Hospital
Start date October 2008
End date September 2014
Trial size 37 participants
Trial identifier NCT00764595, CDR0000615628, NIIGATAU-TRIGIST0805


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Progression-free survival
time frame:

Secondary Outcomes

Overall survival
time frame:
Tumor response
time frame:
Adverse events
time frame:

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
Principal investigator Tatsuo Kanda, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).