Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098527
Status:
TERMINATED
Last Update Posted:
2013-07-02
First Post:
2004-12-07
Brief Title:
FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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 65-10 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 65-10 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA099118 | NIH | None | httpsreporternihgovquickSearchU01CA099118 |
| 6075-04-7R0 | None | None | None |
| DUMC-6075-04-7R0 | None | None | None |
| CDR0000398177 | None | None | None |
| NCI-6351 | None | None | None |