Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003296
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer
Sponsor:
Brown University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of TLC D-99 for Hepatobiliary Carcinomas
Status:
UNKNOWN
Status Verified Date:
2000-09
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 with liver or bile duct cancer
PURPOSE Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with liver or bile duct cancer
Detailed Description:
OBJECTIVES I Determine the response rate and toxicity of doxorubicin HCl liposome in patients with carcinomas of the liver and bile ducts
OUTLINE Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days Filgrastim G-CSF is administered subcutaneously starting on day 2 and continuing for 10-14 days Disease is restaged after every 3 courses Treatment continues in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for the first year and then every 6 months thereafter
PROJECTED ACCRUAL There will be 17-26 evaluable patients accrued into this study
OUTLINE Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days Filgrastim G-CSF is administered subcutaneously starting on day 2 and continuing for 10-14 days Disease is restaged after every 3 courses Treatment continues in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for the first year and then every 6 months thereafter
PROJECTED ACCRUAL There will be 17-26 evaluable patients accrued into 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-V98-1408 | None | None | None |
| BRUOG-HB-71 | None | None | None |