Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193037
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2005-09-12
Brief Title:
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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:
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients with subsequent crossover to the opposite arm at disease progression or patient intolerance We will explore this as well as any possible cross resistance between these two agents
Detailed Description:
Upon determination of eligibility patients will be randomly assigned to one of two treatment arms
Liposomal Doxorubicin
Docetaxel
For ever 2 patients treated 1 will receive treatment A Liposomal Doxorubicin and 1 will receive treatment B Docetaxel Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM provided patient still meets the eligibility laboratory and performance status criteria The study is not blinded so both the patient and the doctor will know which treatment has been assigned
Liposomal Doxorubicin
Docetaxel
For ever 2 patients treated 1 will receive treatment A Liposomal Doxorubicin and 1 will receive treatment B Docetaxel Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM provided patient still meets the eligibility laboratory and performance status criteria The study is not blinded so both the patient and the doctor will know which treatment has been assigned
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