Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005614
Status:
WITHDRAWN
Last Update Posted:
2012-09-25
First Post:
2000-05-02
Brief Title:
Management of Metastatic Breast Cancer in Frail Patients
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Management of Metastatic Breast Cancer in Frail Patients
Status:
WITHDRAWN
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no accrual
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 elderly women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of gemcitabine in treating elderly women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the safety and efficacy of gemcitabine in the treatment of elderly women with metastatic breast cancer II Evaluate the quality of life in these patients
OUTLINE Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8 week course Treatment then continues weekly for 3 consecutive weeks in 4 week courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed prior to treatment and then every 12 weeks Patients are followed every 3 months for 2 years then every 6 months until year 5 and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study over 2 years
OUTLINE Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8 week course Treatment then continues weekly for 3 consecutive weeks in 4 week courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed prior to treatment and then every 12 weeks Patients are followed every 3 months for 2 years then every 6 months until year 5 and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study over 2 years
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-G00-1748 | OTHER | NCI | None |