Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003927
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Amifostine and Peripheral Stem Cell Transplantation in Treating Patients With Stage II Stage III or Stage IV Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
High-Dose Infusional Taxol Amifostine Doxorubicin and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-07
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 Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy amifostine and peripheral stem cell transplantation in treating patients who have stage II stage III or stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy amifostine and peripheral stem cell transplantation in treating patients who have stage II stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES I Evaluate the feasibility of high dose doxorubicin cyclophosphamide paclitaxel and amifostine in patients with high risk stage IIIII and responsive stage IV advanced breast cancer II Determine the pharmacokinetic profile of paclitaxel administered with amifostine in this regimen in these patients III Assess the toxicity of this treatment regimen in this patient population
OUTLINE Patients receive filgrastim G-CSF subcutaneously twice daily on days 1-4 for peripheral blood stem cell PBSC mobilization and continuing through days 5-10 during PBSC collection At least 2 weeks following mobilization patients receive doxorubicin IV as a continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day -5 and amifostine IV over 15 minutes and paclitaxel IV over 24 hours on day -4 On day -2 25 PBSC are reinfused and 75 are reinfused on day 0 followed by daily G-CSF subcutaneously or IV beginning on day 1 Patients are followed every 3 months for 2 years then periodically thereafter
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 6-8 months
OUTLINE Patients receive filgrastim G-CSF subcutaneously twice daily on days 1-4 for peripheral blood stem cell PBSC mobilization and continuing through days 5-10 during PBSC collection At least 2 weeks following mobilization patients receive doxorubicin IV as a continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day -5 and amifostine IV over 15 minutes and paclitaxel IV over 24 hours on day -4 On day -2 25 PBSC are reinfused and 75 are reinfused on day 0 followed by daily G-CSF subcutaneously or IV beginning on day 1 Patients are followed every 3 months for 2 years then periodically thereafter
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 6-8 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 |
|---|---|---|---|
| CDR0000067115 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-IRB-99002 | None | None | None |
| ALZA-CHNMC-IRB-99002 | None | None | None |
| NCI-G99-1527 | None | None | None |