Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003539
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Paclitaxel Plus Monoclonal Antibody Therapy in Treating Women With Recurrent or Metastatic Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Weekly 1-Hour Paclitaxel Taxol Plus Recombinant Humanized Anti-p185HER2 Monoclonal Antibody Herceptin in the Treatment of Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody therapy in treating women with recurrent or metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody therapy in treating women with recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the therapeutic efficacy of paclitaxel in combination with monoclonal antibody HER2 Herceptin in women with recurrent or metastatic breast cancer II Evaluate the safety of this combination regimen in these patients
OUTLINE Patients are stratified by tumor expression of HER2 overexpression vs normal Patients receive a loading dose of monoclonal antibody HER2 Herceptin intravenously over 90 minutes on day 0 Paclitaxel is administered intravenously over 1 hour on day 1 Starting on day 7 patients receive paclitaxel by infusion over 1 hour every 7 days Monoclonal antibody HER2 is administered intravenously over 30 minutes immediately following paclitaxel every 7 days Treatment continues in the absence of disease progression and unacceptable toxicity Patients are followed until death
PROJECTED ACCRUAL This study will accrue 50 patients in approximately 6 months
OUTLINE Patients are stratified by tumor expression of HER2 overexpression vs normal Patients receive a loading dose of monoclonal antibody HER2 Herceptin intravenously over 90 minutes on day 0 Paclitaxel is administered intravenously over 1 hour on day 1 Starting on day 7 patients receive paclitaxel by infusion over 1 hour every 7 days Monoclonal antibody HER2 is administered intravenously over 30 minutes immediately following paclitaxel every 7 days Treatment continues in the absence of disease progression and unacceptable toxicity Patients are followed until death
PROJECTED ACCRUAL This study will accrue 50 patients in approximately 6 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 |
|---|---|---|---|
| CDR0000066593 | REGISTRY | None | None |
| NCI-G98-1473 | Registry Identifier | PDQ Physician Data Query | None |