FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Esophagus
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (romidepsin)
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.