Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005980
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2000-07-05
Brief Title:
Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome
Assess the side effects of these treatment regimens in this patient population
Determine the duration of response in these patients treated with these regimens
Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center performance status 0-1 vs 2 visceral disease yes vs no available lesions for biopsy yes vs no prior adjuvant anthracyclines yes vs no and prior chemotherapy for advanced disease yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks
Arm II Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 64-100 patients 32-50 per treatment arm will be accrued for this study
Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome
Assess the side effects of these treatment regimens in this patient population
Determine the duration of response in these patients treated with these regimens
Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center performance status 0-1 vs 2 visceral disease yes vs no available lesions for biopsy yes vs no prior adjuvant anthracyclines yes vs no and prior chemotherapy for advanced disease yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks
Arm II Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 64-100 patients 32-50 per treatment arm 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 |
|---|---|---|---|
| PAMM-10993 | None | None | None |
| EORTC-IDBBC-10993 | None | None | None |
| ECSG-10993 | None | None | None |