Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002544
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
1999-11-01
Brief Title:
Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
Sponsor:
Arbeitsgemeinschaft fur Internistische Onkologie
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MITOXANTRONE N VS 5-FLUOROURACIL EPIRUBICIN AND CYCLOPHOSPHAMIDE AS FIRST-LINE CHEMOTHERAPY FOR PATIENTS WITH METASTATIC BREAST CANCER AND AN UNFAVORABLE PROGNOSIS
Status:
COMPLETED
Status Verified Date:
2001-04
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 It is not yet known if mitoxantrone is more effective with or without docetaxel
PURPOSE Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis
PURPOSE Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis
Detailed Description:
OBJECTIVES
Compare the survival and quality of life scores composed of time to progression WHO performance status subjective patient evaluation and subjective adverse event profile among women with metastatic breast cancer of unfavorable prognosis treated with mitoxantrone vs mitoxantrone plus docetaxel as first-line chemotherapy for metastatic disease
Compare the remission rate time to remission remission duration time to best response objective adverse events and patient acceptance of treatment on these 2 regimens
Investigate which prognostic subgroups of women benefit from treatment
OUTLINE This is a randomized multicenter study Patients are stratified according to age treatment center disease free interval no more than 18 months vs more than 18 months hormone receptor status positive or unknown vs negative prior adjuvant therapy with anthracyclines yes vs no presence of liver metastases liver involvement as a single organ vs liver plus other organ involvement vs no liver involvement and presence of lung metastases yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive mitoxantrone IV on day 1 Treatment repeats every 3 weeks until disease progression unacceptable toxicity or maximum cumulative dose Patients who achieve complete response receive 2 additional courses
Arm II Patients receive mitoxantrone IV plus docetaxel IV over 1 hour on day 1 Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
At relapse reinduction with the original regimen is attempted Following a second complete response 2 additional courses of consolidative treatment are given and patients are then followed off treatment
Quality of life is assessed periodically
PROJECTED ACCRUAL A total of 300 patients will be accrued for this study
Compare the survival and quality of life scores composed of time to progression WHO performance status subjective patient evaluation and subjective adverse event profile among women with metastatic breast cancer of unfavorable prognosis treated with mitoxantrone vs mitoxantrone plus docetaxel as first-line chemotherapy for metastatic disease
Compare the remission rate time to remission remission duration time to best response objective adverse events and patient acceptance of treatment on these 2 regimens
Investigate which prognostic subgroups of women benefit from treatment
OUTLINE This is a randomized multicenter study Patients are stratified according to age treatment center disease free interval no more than 18 months vs more than 18 months hormone receptor status positive or unknown vs negative prior adjuvant therapy with anthracyclines yes vs no presence of liver metastases liver involvement as a single organ vs liver plus other organ involvement vs no liver involvement and presence of lung metastases yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive mitoxantrone IV on day 1 Treatment repeats every 3 weeks until disease progression unacceptable toxicity or maximum cumulative dose Patients who achieve complete response receive 2 additional courses
Arm II Patients receive mitoxantrone IV plus docetaxel IV over 1 hour on day 1 Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
At relapse reinduction with the original regimen is attempted Following a second complete response 2 additional courses of consolidative treatment are given and patients are then followed off treatment
Quality of life is assessed periodically
PROJECTED ACCRUAL A total of 300 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-93011 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000063279 | REGISTRY | None | None |