Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00098527
Status:
TERMINATED
Last Update Posted:
2013-07-02
First Post:
2004-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of Single Agent Depsipeptide (FK228) in Gastric and Esophageal Cancers
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: