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

Stopped early · Phase 2

Conditions studied: Adenocarcinoma of the Esophagus, Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer, Recurrent Gastric Cancer

In brief

This phase II trial is studying how well FR901228 works in treating patients with refractory stomach cancer or gastroesophageal junction. Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

Key facts

Study ID

NCT00098527

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2004-10-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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