Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005991
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2000-07-05
Brief Title:
Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of Gemcitabine and Doxil Combination Chemotherapy in Patients With Advanced Solid Tumors Phase IBreast Cancer Phase II
Status:
COMPLETED
Status Verified Date:
2018-11
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of gemcitabine and liposomal doxorubicin in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of gemcitabine and liposomal doxorubicin in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES
I Determine the objective response rate duration of response time to disease progression and duration of survival of women with metastatic breast cancer when treated with gemcitabine and doxorubicin HCl liposome
II Determine the qualitative and quantitative toxicity and reversibility of toxicity of this treatment regimen in these patients
OUTLINE Patients receive gemcitabine intravenous IV over 30 minutes on days 1 and 8 and doxorubicin HCl liposome IV over 25 hours on day 1 Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study within 20 months
I Determine the objective response rate duration of response time to disease progression and duration of survival of women with metastatic breast cancer when treated with gemcitabine and doxorubicin HCl liposome
II Determine the qualitative and quantitative toxicity and reversibility of toxicity of this treatment regimen in these patients
OUTLINE Patients receive gemcitabine intravenous IV over 30 minutes on days 1 and 8 and doxorubicin HCl liposome IV over 25 hours on day 1 Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study within 20 months
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 |
|---|---|---|---|
| DM97-127 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-DM-97127 | None | None | None |
| NCI-1650 | None | None | None |