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.
PRIMARY OBJECTIVES: I. Determine the radiographic response rate (complete response and partial response) in patients with refractory adenocarcinoma of the stomach or gastroesophageal junction treated with FR901228 (depsipeptide). SECONDARY OBJECTIVES: I. Determine the median time to progression and progression-free survival of patients treated with this drug. II. Determine the grade 3 and 4 toxic effects of this drug in these patients. OUTLINE: This is an open-label, multicenter study. 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. PROJECTED ACCRUAL: A total of 13-20 patients will be accrued for this study within 6.5-10 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given IV
Correlative studies
Duke University Medical Center
Durham, North Carolina, United States
Radiographic response rate (complete response & partial response)
Time frame: Not Provided
Progression-free survival (PFS) according to RECIST
The median time to progression and median PFS for all eligible patients, along with their CIs, will be reported. The Kaplan-Meier analysis approach may be used to summarize these time-to-event endpoints.
Time frame: Up to more than 6 months
Frequency of treatment related grade 1-4 toxicities and cardiac toxicities as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time frame: Up to 12 months
Correlation of changes in gene expression profile in dermal granulation tissue pre- and post-treatment with gene expression profile
Time frame: Not Provided
Correlation of wound vascular scores pre- and post-treatment with gene/protein changes
Time frame: Not Provided
Toxicity
Time frame: Not Provided
Changes in gene expression profile
Time frame: At pre- and post-treatment
Changes in levels of p21 and thymidine kinase expression, and tubulin acetylation using Western blotting
Time frame: From baseline to 3 weeks
Changes in gene expression profile in dermal granulation tissue
Time frame: From baseline to up to 3 weeks
Change in plasma and urine TGFB levels
Time frame: At pre-and post-treatment
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