A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
Condition: Recurrent Gastric Cancer; Stage IV Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: imatinib mesylate; laboratory biomarker analysis
Intervention description: Given orally; Correlative studies
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for
      tumor cell growth. This phase II trial is studying how well imatinib mesylate works in
      treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal
      junction cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with metastatic and/or unresectable carcinoma of the stomach, who have
             measurable disease

          -  Life expectancy > 3 months

          -  Karnofsky Performance Status > 60%

          -  Absence of an active infection

          -  Granulocyte count of > 1,500/mm^3

          -  Hemoglobin (Hgb) >= 9 mg/dl

          -  Serum bilirubin =< 1.5 mg/dl, regardless of liver involvement secondary to tumor

          -  Platelets > 100,000/mm^3

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
             transaminase (SGPT) < 2.5 x the institutional upper limit of normal

          -  Calculated creatinine clearance of > 60 ml/min

          -  Patients must have signed written informed consent

          -  Female patients of child-bearing potential must have a negative blood or urine
             pregnancy test within two weeks prior to initial study treatment

          -  Patients who have had prior chemotherapy or radiation therapy must have recovered from
             any toxicities prior to study entry

          -  Patients must have radiographic imaging to document measurable disease within 28 days
             prior to initial study therapy

        Exclusion Criteria:

          -  Diagnosis of resectable carcinoma of the stomach

          -  Major surgery within four weeks of study entry

          -  Brain metastasis or known seizure disorder

          -  Fertile men and women not using an acceptable method of contraception

          -  Pregnant or lactating patients are excluded since STI571 may be harmful to the
             developing fetus and child

          -  Patients known to be HIV positive and receiving HAART are excluded because of possibly
             pharmacological interactions

          -  Active peptic ulceration or active gastrointestinal bleeding or any active bleeding
             disorders

          -  Use of therapeutic doses of coumadin (warfarin) as anticoagulation

          -  Medical, social, or psychological factors which would prevent the patient from
             completing the treatment protocol

          -  Patients with serious intercurrent illness which would preclude tolerance and
             completion of the protocol treatment