Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT00062257
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2003-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer
Sponsor:
Cancer Therapeutics Research Group
Organization:
Study Overview
Official Title:
A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2005-03
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:
RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer.
PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer.
Detailed Description:
OBJECTIVES:
* Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.
* Determine the toxicity profile of this drug in these patients.
* Determine the overall survival of patients treated with this drug.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9 months.
* Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.
* Determine the toxicity profile of this drug in these patients.
* Determine the overall survival of patients treated with this drug.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9 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?: