Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004236
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2000-01-28
Brief Title:
Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Caelyx in the Treatment of Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2000-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 liposomal doxorubicin in treating patients who have advanced stomach cancer
PURPOSE Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced stomach cancer
Detailed Description:
OBJECTIVES I Determine overall survival time to disease progression objective reponse rate safety profile and quality of life in patients with inoperable gastric adenocarcinoma when treated with doxorubicin HCl liposome
OUTLINE Patients receive doxorubicin HCl liposome IV over 1 hour every 4 weeks Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression Patients with responding disease may continue therapy past the 6 courses until documented disease progression Quality of life is assessed prior to every treatment course All patients are followed at 1 month Patients with stable or responding disease are then followed every 3 months until death
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 24 months
OUTLINE Patients receive doxorubicin HCl liposome IV over 1 hour every 4 weeks Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression Patients with responding disease may continue therapy past the 6 courses until documented disease progression Quality of life is assessed prior to every treatment course All patients are followed at 1 month Patients with stable or responding disease are then followed every 3 months until death
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 24 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 |
|---|---|---|---|
| EU-99034 | None | None | None |
| LRI-IND02-398 | None | None | None |