NCT00098527

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

A Phase 2 Study of Single Agent Depsipeptide (FK228) in Gastric and Esophageal Cancers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Stomach
• Recurrent Esophageal Cancer
• Recurrent Gastric Cancer

Interventions

Type	Name	Description
DRUG	romidepsin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-09-01
• First posted: 2004-12-08
• Last updated: 2013-07-02

Locations

1 site across 1 country: United States