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

Metastatic Cancer Clinical Trial

— GISTs  

Official title:

Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764595
• Other study ID #: CDR0000615628
• Secondary ID: NIIGATAU-TRIGIST
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: March 2016

Study information

• Verified date: July 2023
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• imatinib mesylate
Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient.

Locations

Country	Name	City	State
Japan	University of Yamanashi Hospital	Chuo	Yamanashi
Japan	Kyushu University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hirosaki University, School of Medicine	Hirosaki	Aomori
Japan	Niigata Prefectural Central Hospital	Joetsu	Niigata
Japan	Kagoshima University	Kagoshima
Japan	Kyoto Second Red Cross Hospital	Kanigyou-ku	Kyoto
Japan	Kimitsu Chuo Hospital	Kisarazu-city
Japan	University of Miyazaki Hospital	Kiyotake	Miyazaki
Japan	Kochi Health Sciences Center	Kochi
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kawasaki Medical School	Kurashiki	Okayama
Japan	National Hospital Organization Kure Medical Center	Kure	Hiroshima
Japan	Nagaoka Chuo General Hospital	Nagaoka	Niigata
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Aichi Medical University	Nagoya	Aichi
Japan	Kochi Medical School	Nankoku	Kochi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Ryukyu University Hospital	Nishiharacho	Okinawa
Japan	Okayama University Hospital	Okayama
Japan	Sakai Municipal Hospital	Sakai	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Juntendo University Shizuoka Hospital	Shizuoka
Japan	Shizuoka Cancer Center	Shizuoka
Japan	Osaka University Hospital	Suita	Osaka
Japan	Tokushima University Hospital	Tokushima
Japan	Keio University Hospital	Tokyo
Japan	Tokyo Metropolitan - Komagome Hospital	Tokyo
Japan	Toyama University Hospital	Toyama
Japan	Toyonaka Municipal Hospital	Toyonaka	Osaka
Japan	International Goodwill Hospital	Yokohama	Kanagawa
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa
Japan	Oita University Hospital	Yufu	Oita

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Niigata University Medical & Dental Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression-free survival is defined as time from date of starting protocol treatment until date of comfirmation of progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 or death from any cause, whichever comes first.	7.5 years
Secondary	Tumor response	Tumor response is defined as best overall response by RECIST v1.0 from date of starting protocol treatment until 48 weeks after starting protocol treatment.	48 weeks
Secondary	Overall survival	Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.	7.5 years
Secondary	Types and severities of adverse events	Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.	7.5 years