Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031876
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2002-03-08
Brief Title:
Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Phase III Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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 more than one drug may kill more tumor cells
PURPOSE Phase III trial to determine the effectiveness of combining capecitabine and paclitaxel in treating patients who have metastatic breast cancer
PURPOSE Phase III trial to determine the effectiveness of combining capecitabine and paclitaxel in treating patients who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of capecitabine when combined with paclitaxel in patients with metastatic adenocarcinoma of the breast
Determine the clinical efficacy of the dose immediately preceding the MTD identified in phase I in terms of response rate time to treatment failure time to disease progression and overall survival in these patients
Determine the toxicity of this regimen in these patients
Determine a well-tolerated drug combination for these patients
OUTLINE This is a dose-escalation multicenter study of capecitabine
Patients receive oral capecitabine twice daily on days 1-14 and paclitaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 21 days for a maximum of 6 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 at which 2 or more of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the dose level immediately preceding the MTD
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for phase I and 15-46 patients will be accrued for phase II of this study
Determine the maximum tolerated dose MTD of capecitabine when combined with paclitaxel in patients with metastatic adenocarcinoma of the breast
Determine the clinical efficacy of the dose immediately preceding the MTD identified in phase I in terms of response rate time to treatment failure time to disease progression and overall survival in these patients
Determine the toxicity of this regimen in these patients
Determine a well-tolerated drug combination for these patients
OUTLINE This is a dose-escalation multicenter study of capecitabine
Patients receive oral capecitabine twice daily on days 1-14 and paclitaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 21 days for a maximum of 6 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 at which 2 or more of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the dose level immediately preceding the MTD
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for phase I and 15-46 patients will be accrued for phase II 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 |
|---|---|---|---|
| EU-20135 | None | None | None |