Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003540
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol
Status:
COMPLETED
Status Verified Date:
2013-06
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
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel
Detailed Description:
OBJECTIVES
Determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens including doxorubicin and paclitaxel
Characterize the nature of toxicity of gemcitabine in this patient population
Determine the response duration to gemcitabine in this patient population
OUTLINE Patients receive gemcitabine IV over 30 minutes once weekly for 3 consecutive weeks days 1 8 and 15 followed by 1 week of rest Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects
Patients are followed until death
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 13 months
Determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens including doxorubicin and paclitaxel
Characterize the nature of toxicity of gemcitabine in this patient population
Determine the response duration to gemcitabine in this patient population
OUTLINE Patients receive gemcitabine IV over 30 minutes once weekly for 3 consecutive weeks days 1 8 and 15 followed by 1 week of rest Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects
Patients are followed until death
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 13 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 |
|---|---|---|---|
| NCI-G98-1474 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066594 | REGISTRY | None | None |