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

NCT00764595 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000615628NIIGATAU-TRIGIST0805
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 36

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.

Conditions

Gastrointestinal Stromal Tumor; Metastatic Cancer

Keywords

gastrointestinal stromal tumor; liver metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tumor response

  48 weeks

• Overall survival

  7.5 years

• Types and severities of adverse events

  7.5 years

Study Arms (1)

imatinib mesylate

EXPERIMENTAL

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

Interventions

imatinib mesylate DRUG

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

imatinib mesylate

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Niigata University Medical & Dental Hospital: collaborator

Study Sites (36)

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

Aichi Medical University

Nagoya, Aichi-ken, 480-1195, Japan

Location

Hirosaki University, School of Medicine

Hirosaki, Aomori, 036-8562, Japan

Location

National Hospital Organization Kure Medical Center

Kure, Hiroshima, 737-0023, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-0815, Japan

Location

International Goodwill Hospital

Yokohama, Kanagawa, 245-0006, Japan

Location

Kochi Medical School

Nankoku, Kochi, 783-8505, Japan

Location

Kyoto Second Red Cross Hospital

Kanigyou-ku, Kyoto, 602-8026, Japan

Location

University of Miyazaki Hospital

Kiyotake, Miyazaki, 889-1692, Japan

Location

Niigata Prefectural Central Hospital

Jōetsu, Niigata, 943-0192, Japan

Location

Nagaoka Chuo General Hospital

Nagaoka, Niigata, 940-8653, Japan

Location

Oita University Hospital

Yufu, Oita Prefecture, 879-5593, Japan

Location

Kawasaki Medical School

Kurashiki, Okayama-ken, 701-01, Japan

Location

Ryukyu University Hospital

Nishiharacho, Okinawa, 903-0215, Japan

Location

Sakai Municipal Hospital

Sakai, Osaka, 590-0064, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Toyonaka Municipal Hospital

Toyonaka, Osaka, 560-8565, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1241, Japan

Location

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Location

University of Yamanashi Hospital

Chūō, Yamanashi, 409-3898, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Kagoshima University

Kagoshima, 890-8520, Japan

Location

Kimitsu Chuo Hospital

Kisarazu, 292-8535, Japan

Location

Kochi Health Sciences Center

Kochi, 781-8555, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Niigata University Medical and Dental Hospital

Niigata, 951-8510, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Juntendo University Shizuoka Hospital

Shizuoka, 410-2295, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Tokyo Metropolitan - Komagome Hospital

Tokyo, 113-0021, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Neoplasm Metastasis

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Tatsuo Kanda, MD

  Niigata University Medical & Dental Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

JP (36)