Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346229
Status:
TERMINATED
Last Update Posted:
2016-03-22
First Post:
2006-06-28
Brief Title:
Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase I Dose Escalation and Pharmacokinetics Study of Temperature Sensitive Liposome Encapsulated Doxorubicin ThermoDox and Hyperthermia in Patients With Local-Regionally Recurrent Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
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 such as liposomal doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature Giving temperature-sensitive liposomal doxorubicin together with hyperthermia may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating women with locally recurrent breast cancer
PURPOSE This phase I trial is studying the side effects and best dose of temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating women with locally recurrent breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of temperature-sensitive liposomal doxorubicin ThermoDox when used in combination with local-regional hyperthermia in women with locally recurrent breast cancer
Determine the pharmacokinetic profile of ThermoDox when used in multiple-course dosing
OUTLINE This is a dose-escalation study of temperature-sensitive liposomal doxorubicin ThermoDox
Patients receive ThermoDox IV over 30 minutes immediately followed by hyperthermia to the chest wallaxilla over 1-2 hours on day 1 Treatment repeats every 21-35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ThermoDox with or without standard-dose granulocyte colony-stimulating factor G-CSF support until the maximum tolerated dose MTD is determined The MTD without G-CSF support is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity DLT At least 6 patients are treated at the MTD If the only DLT is neutropenia in 1 of 6 patients treated at any dose level then additional cohorts of 3-6 patients receive escalating doses of ThermoDox with G-CSF support standard-dose G-CSF or standard-dose pegfilgrastim until the MTD is determined The MTD with G-CSF support is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT after the addition of G-CSF support
Quality of life and pain are assessed at baseline prior to courses 3 and 5 and at 21-42 days after completion of therapy
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Determine the maximum tolerated dose of temperature-sensitive liposomal doxorubicin ThermoDox when used in combination with local-regional hyperthermia in women with locally recurrent breast cancer
Determine the pharmacokinetic profile of ThermoDox when used in multiple-course dosing
OUTLINE This is a dose-escalation study of temperature-sensitive liposomal doxorubicin ThermoDox
Patients receive ThermoDox IV over 30 minutes immediately followed by hyperthermia to the chest wallaxilla over 1-2 hours on day 1 Treatment repeats every 21-35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ThermoDox with or without standard-dose granulocyte colony-stimulating factor G-CSF support until the maximum tolerated dose MTD is determined The MTD without G-CSF support is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity DLT At least 6 patients are treated at the MTD If the only DLT is neutropenia in 1 of 6 patients treated at any dose level then additional cohorts of 3-6 patients receive escalating doses of ThermoDox with G-CSF support standard-dose G-CSF or standard-dose pegfilgrastim until the MTD is determined The MTD with G-CSF support is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT after the addition of G-CSF support
Quality of life and pain are assessed at baseline prior to courses 3 and 5 and at 21-42 days after completion of therapy
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| CDR0000482411 | OTHER | Secondary ID | None |
| DUMC-6883-06-2R1 | None | None | None |
| DUMC-06068 | None | None | None |