Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006108
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2000-08-03
Brief Title:
Capecitabine Paclitaxel and Trastuzumab in Treating Patients With Metastatic Breast Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Trial of Xeloda Every Three Week Taxol and Herceptin in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-02
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 such as trastuzumab 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 tumor cells
PURPOSE Phase III trial to study the effectiveness of combining capecitabine paclitaxel and trastuzumab in treating patients who have metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of combining capecitabine paclitaxel and trastuzumab in treating patients who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of capecitabine when administered in combination with paclitaxel and trastuzumab Herceptin in patients with metastatic breast cancer II Determine the response rate of these patients to this treatment regimen III Determine the median time to treatment failure in these patients with this treatment regimen IV Determine the incidence of cardiac toxicity in these patients with this treatment regimen V Assess the quality of life in these patients
OUTLINE This is a dose escalation study of capecitabine Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 paclitaxel IV over 3 hours on day 2 and oral capecitabine on days 3-16 Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Once the MTD is determined additional patients are accrued Quality of life is assessed at baseline and after 3 courses of treatment
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for the phase I dose escalation portion of this study A total of 28-41 patients will be accrued for the phase II portion of this study
OUTLINE This is a dose escalation study of capecitabine Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 paclitaxel IV over 3 hours on day 2 and oral capecitabine on days 3-16 Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Once the MTD is determined additional patients are accrued Quality of life is assessed at baseline and after 3 courses of treatment
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for the phase I dose escalation portion of this study A total of 28-41 patients will be accrued for the phase II portion of this study
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 |
|---|---|---|---|
| CDR0000068119 | OTHER | PDQ number | None |
| UNC-9904 | None | None | None |
| NCI-G00-1834 | REGISTRY | None | None |