Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010075
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2001-02-02
Brief Title:
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
Status:
UNKNOWN
Status Verified Date:
2003-06
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 Combining more than one chemotherapy drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium fluorouracil and mitoxantrone
Determine the efficacy of this regimen in terms of response and survival without progression in these patients
Determine the tolerance of these patients to this regimen
OUTLINE This is a multicenter study
Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1 Patients then receive fluorouracil IV over 46 hours on days 1-2 Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after 3 courses and at treatment completion
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study
Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium fluorouracil and mitoxantrone
Determine the efficacy of this regimen in terms of response and survival without progression in these patients
Determine the tolerance of these patients to this regimen
OUTLINE This is a multicenter study
Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1 Patients then receive fluorouracil IV over 46 hours on days 1-2 Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after 3 courses and at treatment completion
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 39 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 |
|---|---|---|---|
| EU-20028 | None | None | None |
| FRE-GERCOR-SAM-S99-1 | None | None | None |