Clinical trial: FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer (NCT00098527)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? 1