FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
• •Measurable disease
• •* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• •Refractory\* to at least 1, but no more than 3, of the following first-line agents:
• •* Fluoropyrimidine (e.g., capecitabine or fluorouracil)
• •* Taxane (e.g., paclitaxel or docetaxel)
• •* Platinum (e.g., carboplatin, cisplatin, or oxaliplatin)
• •No known active brain metastases
• •* Treated brain metastases allowed provided metastases are stable off steroids for ≥ 30 days
• •Performance status - ECOG 0-2
• •Performance status - Karnofsky 60-100%
• •At least 3 months
• •WBC ≥ 3,000/mm\^3
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
• •Creatinine clearance ≥ 50 mL/min
• •No congestive heart failure
• •No New York Heart Association class III or IV heart disease
• •No myocardial infarction within the past 6 months
• •No ventricular arrhythmias requiring medication
• •No angioplasty or vascular stenting within the past 3 months
• •No unstable angina
• •No left ventricular hypertrophy by EKG
• •No known history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
• •QTc \< 500 msec
• •LVEF \> 40% by MUGA or echocardiogram
• •No other significant cardiac disease
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Potassium ≥ 4.0 mmol/L (stable level with no change in supplementation within the past 2 weeks)
• •Magnesium ≥ 2.0 mg/dL (stable level with no change in supplementation within the past 2 weeks)
• •No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug
• •No ongoing or active infection
• •No psychiatric illness or social situation that would preclude study compliance
• •No other uncontrolled illness
• •Prior biological agents allowed
• •No concurrent prophylactic filgrastim (G-CSF)
• •No concurrent biologic therapy
• •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• •No other concurrent chemotherapy
• •More than 4 weeks since prior radiotherapy and recovered
• •No concurrent radiotherapy
• •Prior targeted agents allowed
• •No other prior or concurrent cytotoxic agents
• •No other concurrent investigational agents
• •No other concurrent anticancer therapy
• •No concurrent medications causing QTc prolongation
• •No concurrent potassium supplementation \> 40 mg/day or magnesium supplementation \> 1 g/week
• •No concurrent hydrochlorothiazide
• •No concurrent combination antiretroviral therapy for HIV-positive patients