Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004906
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2000-03-07
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer
Sponsor:
Hackensack Meridian Health
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Multi-Institution Study of Docetaxel and Doxorubicin as Induction Therapy Followed by Sequential High Dose Chemotherapy and CD 34 Selected Stem Cell Support for Women With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-11
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Assess the toxicity and response rates to induction therapy with docetaxel and doxorubicin in women with chemotherapy naive metastatic breast cancer II Assess the toxicity and response rates to sequential high dose chemotherapy following induction chemotherapy in women with metastatic breast cancer III Determine the hematopoietic recovery rate following CD34 selected peripheral blood stem cell support in this patient population IV Assess the toxicity of noncytotoxic maintenance therapy following high dose chemotherapy in this patient population
OUTLINE This is a multicenter study Patients with no prior chemotherapy for metastatic disease receive induction chemotherapy consisting of doxorubicin IV immediately followed by docetaxel IV over 1 hour on day 1 Patients receive filgrastim G-CSF subcutaneously SQ beginning on day 2 and continuing until day 11-15 Induction therapy repeats every 3 weeks for 4 courses Within 4 weeks of the last course of induction chemotherapy patients receive mobilization chemotherapy consisting of cyclophosphamide IV for 2 days and etoposide IV and cisplatin IV for 3 days At 24 hours following completion of chemotherapy patients receive G-CSF SQ twice daily until the target number of peripheral blood stem cells PBSC are reached Within 5 weeks following completion of mobilization chemotherapy patients receive cyclophosphamide IV thiotepa IV and carboplatin IV continuously on days -7 through -4 Patients receive CD34 selected PBSC on day 0 followed 4 hours later by G-CSF SQ daily and continuing until blood counts recover Within 30 days of blood count recovery or immediately following completion of post transplantation radiotherapy patients receive maintenance therapy consisting of oral anastrozole daily until disease progression Patients with bone involvement also receive pamidronate IV over 2 hours monthly for 1 year Patients are followed monthly for 6 months every 3 months for 1 year every 4-6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over 12 months
OUTLINE This is a multicenter study Patients with no prior chemotherapy for metastatic disease receive induction chemotherapy consisting of doxorubicin IV immediately followed by docetaxel IV over 1 hour on day 1 Patients receive filgrastim G-CSF subcutaneously SQ beginning on day 2 and continuing until day 11-15 Induction therapy repeats every 3 weeks for 4 courses Within 4 weeks of the last course of induction chemotherapy patients receive mobilization chemotherapy consisting of cyclophosphamide IV for 2 days and etoposide IV and cisplatin IV for 3 days At 24 hours following completion of chemotherapy patients receive G-CSF SQ twice daily until the target number of peripheral blood stem cells PBSC are reached Within 5 weeks following completion of mobilization chemotherapy patients receive cyclophosphamide IV thiotepa IV and carboplatin IV continuously on days -7 through -4 Patients receive CD34 selected PBSC on day 0 followed 4 hours later by G-CSF SQ daily and continuing until blood counts recover Within 30 days of blood count recovery or immediately following completion of post transplantation radiotherapy patients receive maintenance therapy consisting of oral anastrozole daily until disease progression Patients with bone involvement also receive pamidronate IV over 2 hours monthly for 1 year Patients are followed monthly for 6 months every 3 months for 1 year every 4-6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over 12 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 |
|---|---|---|---|
| NCI-G00-1682 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067586 | REGISTRY | None | None |