Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003748
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Esophageal or Stomach Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Irinotecan CPT-11 in Adenocarcinoma of the Esophagus and Gastric Cardia
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer
Detailed Description:
OBJECTIVES I Determine the antitumor activity of irinotecan in patients with adenocarcinoma of the esophagus or gastric cardia II Evaluate the toxicities of this drug in this patient population
OUTLINE This is a multicenter study Patients receive irinotecan intravenous IV over 90 minutes once a week for 4 weeks followed by a 2 week rest period Treatment continues in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive irinotecan intravenous IV over 90 minutes once a week for 4 weeks followed by a 2 week rest period Treatment continues in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G99-1497 | None | None | None |
| UCLA-HSPC-9703008 | None | None | None |
| P-UPHJOHN-6475-96014 | None | None | None |