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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Cancer; Gastrointestinal Stromal Tumor
• Intervention / Treatment: Drug: imatinib mesylate

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Kagoshima, Japan, 890-8520
    • Kagoshima University
  • Kisarazu-city, Japan, 292-8535
    • Kimitsu Chuo Hospital
  • Kochi, Japan, 781-8555
    • Kochi Health Sciences Center
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Niigata, Japan, 951-8510
    • Niigata University Medical and Dental Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Shizuoka, Japan, 410-2295
    • Juntendo University Shizuoka Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
  • Tokyo, Japan, 113-0021
    • Tokyo Metropolitan - Komagome Hospital
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center
    • Nagoya, Aichi, Japan, 480-1195
      • Aichi Medical University
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8562
      • Hirosaki University, School of Medicine
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-0023
      • National Hospital Organization Kure Medical Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-0815
      • Kanagawa Cancer Center
    • Yokohama, Kanagawa, Japan, 245-0006
      • International Goodwill Hospital
  • Kochi
    • Nankoku, Kochi, Japan, 783-8505
      • Kochi Medical School
  • Kyoto
    • Kanigyou-ku, Kyoto, Japan, 602-8026
      • Kyoto Second Red Cross Hospital
  • Miyazaki
    • Kiyotake, Miyazaki, Japan, 889-1692
      • University of Miyazaki Hospital
  • Niigata
    • Joetsu, Niigata, Japan, 943-0192
      • Niigata Prefectural Central Hospital
    • Nagaoka, Niigata, Japan, 940-8653
      • Nagaoka Chuo General Hospital
  • Oita
    • Yufu, Oita, Japan, 879-5593
      • Oita University Hospital
  • Okayama
    • Kurashiki, Okayama, Japan, 701-01
      • Kawasaki Medical School
  • Okinawa
    • Nishiharacho, Okinawa, Japan, 903-0215
      • Ryukyu University Hospital
  • Osaka
    • Sakai, Osaka, Japan, 590-0064
      • Sakai Municipal Hospital
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
    • Toyonaka, Osaka, Japan, 560-8565
      • Toyonaka Municipal Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1241
      • Saitama Medical University International Medical Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University School of Medicine
  • Yamanashi
    • Chuo, Yamanashi, Japan, 409-3898
      • University of Yamanashi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: imatinib mesylate; All patients start imatinib mesylate as oral dose of 400 mg/d once daily after meal within 28 days after enrollment, and continue the treatment until 3 years after enrollment of the last patient.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Overall survival	Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.	7.5 years

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Niigata University Medical & Dental Hospital
• Investigators: Principal Investigator: Tatsuo Kanda, MD, Niigata University Medical & Dental Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimated): October 2, 2008

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: liver metastases; gastrointestinal stromal tumor
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplastic Processes; Neoplasms, Connective Tissue; Neoplasm Metastasis; Gastrointestinal Stromal Tumors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: CDR0000615628; NIIGATAU-TRIGIST0805 (Other Identifier: Niigata University Medical and Dental Hosptial)