Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062257
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2003-06-05
Brief Title:
Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer
Sponsor:
Cancer Therapeutics Research Group
Organization:
National Cancer Institute NCI
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-6041 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000304669 | REGISTRY | None | None |