Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002628
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
1999-11-01
Brief Title:
Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast Cancer
Sponsor:
St Louis University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III TRIAL OF THE ADDITION OF TAXOL TO THE HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH BREAST CANCER
Status:
UNKNOWN
Status Verified Date:
2000-04
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 drug may kill more tumor cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells allowing higher doses of chemotherapy to be used
PURPOSE Phase III trial to study the effectiveness of paclitaxel added to a regimen of high-dose chemotherapy with cyclophosphamide and carboplatin followed by peripheral stem cell transplantation in treating women with metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of paclitaxel added to a regimen of high-dose chemotherapy with cyclophosphamide and carboplatin followed by peripheral stem cell transplantation in treating women with metastatic breast cancer
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of paclitaxel in combination with high-dose carboplatincyclophosphamide followed by autologous peripheral blood stem cell support in women with stage IV breast cancer II Assess the nonhematologic toxic effects associated with this combination III Assess the response rate duration of response and survival in chemotherapy-sensitive women with metastatic breast cancer treated with this regimen
OUTLINE This is a dose-finding study All patients undergo collection of peripheral blood stem cells PBSC with granulocyte colony-stimulating factor G-CSF mobilization prior to high-dose chemotherapy Cohorts of 3-5 patients are treated at successively higher dose levels of paclitaxel until a maximum tolerated dose MTD is found Paclitaxel is given as a single 24-hour infusion followed by fixed doses of high-dose cyclophosphamide for 2 days then carboplatin for 4 days Three days later patients receive PBSC and G-CSF for hematopoietic reconstitution Additional patients are entered at the MTD Patients are followed every 3 months for 1 year every 4 months for 1 year and every 4-6 months thereafter
PROJECTED ACCRUAL 50 patients will be accrued The study is expected to take 18 months
OUTLINE This is a dose-finding study All patients undergo collection of peripheral blood stem cells PBSC with granulocyte colony-stimulating factor G-CSF mobilization prior to high-dose chemotherapy Cohorts of 3-5 patients are treated at successively higher dose levels of paclitaxel until a maximum tolerated dose MTD is found Paclitaxel is given as a single 24-hour infusion followed by fixed doses of high-dose cyclophosphamide for 2 days then carboplatin for 4 days Three days later patients receive PBSC and G-CSF for hematopoietic reconstitution Additional patients are entered at the MTD Patients are followed every 3 months for 1 year every 4 months for 1 year and every 4-6 months thereafter
PROJECTED ACCRUAL 50 patients will be accrued The study is expected to take 18 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-V95-0608 | None | None | None |
| SLUMC-7915 | None | None | None |