Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006433
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-11-03
Brief Title:
Phase III Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
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:
Purpose The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy This protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast Doxil is the drug adriamycin also called doxorubicin encapsulated in liposomes which coats the drug with a small amount of lipid fat This chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity We are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor which may give an increased tumor response
Methods The patients will be treated with chemotherapy followed by heat treatment This will be given for 6 cycles approximately every 4 weeks For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor
Methods The patients will be treated with chemotherapy followed by heat treatment This will be given for 6 cycles approximately every 4 weeks For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor
Detailed Description:
None
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 |
|---|---|---|---|
| M01RR000030 | NIH | None | httpsreporternihgovquickSearchM01RR000030 |