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


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumor, Metastatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Tatsuo Kanda, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Niigata University Medical and Dental Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000615628

NCT ID:

NCT00764595

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Metastatic Cancer
  • gastrointestinal stromal tumor
  • liver metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Gastrointestinal Stromal Tumors

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