Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012311
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-03-03
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multi-Cycle High-Dose Chemotherapy Versus Optimized Conventionally-Dosed Chemotherapy in Patients With Metastatic Breast Cancer A Phase II Prospective Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2001-09
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 Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells It is not yet known if chemotherapy followed by peripheral stem cell transplantation is more effective than chemotherapy alone in treating metastatic breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation with that of chemotherapy alone in treating women who have stage IV breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation with that of chemotherapy alone in treating women who have stage IV breast cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of multi-course high-dose chemotherapy with autologous peripheral blood stem cell transplantation versus standard-dose chemotherapy in women with metastatic breast cancer II Compare the five year event-free survival in terms of time to progression or time to death due to toxic effects in patients treated with these regimens III Compare the response rate and overall survival of patients treated with these regimens IV Compare the toxicity of these regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive docetaxel and doxorubicin once followed by filgrastim G-CSF daily for approximately 1 week Treatment repeats approximately every 3 weeks for 4 courses Patients then receive cyclophosphamide methotrexate and fluorouracil on days 7 and 8 every 4 weeks for 4 courses Arm II Patients receive docetaxel doxorubicin and G-CSF as in arm I for 3 courses Patients undergo leukapheresis daily for 3 or 4 days Patients then receive 1 course of ifosfamide etoposide and carboplatin daily for 4 days when blood counts recover followed by 1 course of cyclophosphamide and thiotepa daily for 4 days Patients undergo peripheral blood stem cell reinfusion following each course
PROJECTED ACCRUAL A total of 264 patients 132 per arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive docetaxel and doxorubicin once followed by filgrastim G-CSF daily for approximately 1 week Treatment repeats approximately every 3 weeks for 4 courses Patients then receive cyclophosphamide methotrexate and fluorouracil on days 7 and 8 every 4 weeks for 4 courses Arm II Patients receive docetaxel doxorubicin and G-CSF as in arm I for 3 courses Patients undergo leukapheresis daily for 3 or 4 days Patients then receive 1 course of ifosfamide etoposide and carboplatin daily for 4 days when blood counts recover followed by 1 course of cyclophosphamide and thiotepa daily for 4 days Patients undergo peripheral blood stem cell reinfusion following each course
PROJECTED ACCRUAL A total of 264 patients 132 per arm will be accrued for this study
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-G01-1922 | None | None | None |
| CPMC-IRB-9244 | None | None | None |