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