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