Clinical trial NCT00764595: Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
Official title: Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumor
Metastatic Cancer
Keywords: gastrointestinal stromal tumor
liver metastases
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Niigata University Medical & Dental Hospital
First posted: 2008-10-02
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 7.5 years
Secondary outcomes:
measure: Tumor response
timeFrame: 48 weeks
measure: Overall survival
timeFrame: 7.5 years
measure: Types and severities of adverse events
timeFrame: 7.5 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Medical University
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University, School of Medicine
state: Aomori
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama
country: Japan
facility: International Goodwill Hospital
state: Kanagawa
city: Nankoku
country: Japan
facility: Kochi Medical School
state: Kochi
city: Kanigyou-ku
country: Japan
facility: Kyoto Second Red Cross Hospital
state: Kyoto
city: Kiyotake
country: Japan
facility: University of Miyazaki Hospital
state: Miyazaki
city: Joetsu
country: Japan
facility: Niigata Prefectural Central Hospital
state: Niigata
city: Nagaoka
country: Japan
facility: Nagaoka Chuo General Hospital
state: Niigata
city: Yufu
country: Japan
facility: Oita University Hospital
state: Oita
city: Kurashiki
country: Japan
facility: Kawasaki Medical School
state: Okayama
city: Nishiharacho
country: Japan
facility: Ryukyu University Hospital
state: Okinawa
city: Sakai
country: Japan
facility: Sakai Municipal Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Toyonaka
country: Japan
facility: Toyonaka Municipal Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University
city: Kisarazu-city
country: Japan
facility: Kimitsu Chuo Hospital
city: Kochi
country: Japan
facility: Kochi Health Sciences Center
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Shizuoka
country: Japan
facility: Juntendo University Shizuoka Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan - Komagome Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
Study officials:
affiliation: Niigata University Medical & Dental Hospital
name: Tatsuo Kanda, MD
role: PRINCIPAL_INVESTIGATOR
References: