Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027989
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-12-07
Brief Title:
Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
Sponsor:
Pharmatech Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Label Single-Arm Phase II Study of Liposomal Doxorubicin Doxil and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2004-04
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 combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine
Determine the duration of response time to disease progression and duration of survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the quantitative toxicity of this regimen in terms of incidence type and severity in these patients
OUTLINE This is a multicenter study
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 courses beyond documentation of CR
Quality of life is assessed at baseline on day 1 of each course and then at the end of study
Patients are followed at 4 weeks and then every 3 months for 5 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine
Determine the duration of response time to disease progression and duration of survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the quantitative toxicity of this regimen in terms of incidence type and severity in these patients
OUTLINE This is a multicenter study
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 courses beyond documentation of CR
Quality of life is assessed at baseline on day 1 of each course and then at the end of study
Patients are followed at 4 weeks and then every 3 months for 5 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
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 |
|---|---|---|---|
| PHARMATECH-P01-00002008 | None | None | None |
| ORTHO-PHARMATECH-P01-000020008 | None | None | None |
| PHARMATECH-20002183 | None | None | None |