Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002627
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 Patients With High-Risk Breast Cancer
Sponsor:
St Louis University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III TRIAL OF THE ADDITION OF TAXOL TO HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH HIGH RISK STAGE II AND III BREAST CANCER
Status:
UNKNOWN
Status Verified Date:
2000-07
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 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 when added to high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating women with breast cancer at high risk of relapse
PURPOSE Phase III trial to study the effectiveness of paclitaxel when added to high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating women with breast cancer at high risk of relapse
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of paclitaxel when given with high-dose carboplatincyclophosphamide with autologous peripheral blood stem cell support in women with high-risk stage IIIII breast cancer II Assess the nonhematologic toxicities associated with this combination III Assess the progression-free and overall survival of these patients following this treatment
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 6-hour infusion followed by fixed doses of high-dose cyclophosphamide for 2 days then carboplatin for 3 days Four 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 then every 4-6 months thereafter
PROJECTED ACCRUAL It is expected that 24-30 patients will be accrued a study duration of 1-15 years is anticipated
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 6-hour infusion followed by fixed doses of high-dose cyclophosphamide for 2 days then carboplatin for 3 days Four 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 then every 4-6 months thereafter
PROJECTED ACCRUAL It is expected that 24-30 patients will be accrued a study duration of 1-15 years is anticipated
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-V95-0607 | None | None | None |
| SLUMC-8038 | None | None | None |