Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077337
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2004-02-10
Brief Title:
FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Depsipeptide NSC-630176 in Colorectal Cancer Patients Who Have Received Either One or Two Prior Chemotherapy Regimens for Metastatic or Locally Advanced Unresectable Disease
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well FR901228 works in treating patients with unresectable locally advanced or metastatic colorectal cancer
PURPOSE This phase II trial is studying how well FR901228 works in treating patients with unresectable locally advanced or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the confirmed response complete and partial in patients with previously treated unresectable locally advanced or metastatic colorectal cancer treated with FR901228 depsipeptide
Determine the time to treatment failure and overall survival of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
OUTLINE This is a 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
Patients are followed every 8 weeks until disease progression and then every 3 months until 1 year after study entry and then every 6 months until 3 years after study entry
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 4-10 months
Determine the confirmed response complete and partial in patients with previously treated unresectable locally advanced or metastatic colorectal cancer treated with FR901228 depsipeptide
Determine the time to treatment failure and overall survival of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
OUTLINE This is a 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
Patients are followed every 8 weeks until disease progression and then every 3 months until 1 year after study entry and then every 6 months until 3 years after study entry
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 4-10 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 |
|---|---|---|---|
| SWOG-S0336 | None | None | None |