Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003902
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
1999-11-01
Brief Title:
Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Phase III of Capecitabine and Vinorelbine in Elderly Patients At Least 65 Years With Metastatic Breast Cancer With or Without Bone Involvement
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 This phase III trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement
PURPOSE This phase III trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of capecitabine and vinorelbine in elderly women 65 and older with metastatic breast cancer
Evaluate the efficacy and tolerability of this regimen in these patients
Assess the time to treatment failure for this regimen as a first line chemotherapy in these patients
OUTLINE This is a dose-escalation study of capecitabine and vinorelbine Patients are stratified according to bone involvement yes closed to accrual as of 12704 vs no
Phase I Patients receive oral capecitabine twice daily on days 1-14 and vinorelbine IV over 6-10 minutes on days 1 and 8 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 and vinorelbine until the maximum tolerated dose MTD of each drug is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity
Phase II Patients receive capecitabine and vinorelbine administered as in phase I at the dose preceding the MTD
Quality of life is assessed during phase II on days 1 8 and 15 of course 1 and on day 1 of courses 2-4
Patients are followed every 3 months until disease progression or start of any subsequent antitumor treatment
PROJECTED ACCRUAL A total of 98-110 patients will be accrued for this study
Determine the maximum tolerated dose of capecitabine and vinorelbine in elderly women 65 and older with metastatic breast cancer
Evaluate the efficacy and tolerability of this regimen in these patients
Assess the time to treatment failure for this regimen as a first line chemotherapy in these patients
OUTLINE This is a dose-escalation study of capecitabine and vinorelbine Patients are stratified according to bone involvement yes closed to accrual as of 12704 vs no
Phase I Patients receive oral capecitabine twice daily on days 1-14 and vinorelbine IV over 6-10 minutes on days 1 and 8 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 and vinorelbine until the maximum tolerated dose MTD of each drug is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity
Phase II Patients receive capecitabine and vinorelbine administered as in phase I at the dose preceding the MTD
Quality of life is assessed during phase II on days 1 8 and 15 of course 1 and on day 1 of courses 2-4
Patients are followed every 3 months until disease progression or start of any subsequent antitumor treatment
PROJECTED ACCRUAL A total of 98-110 patients will be accrued for 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-99007 | None | None | None |
| SWS-SAKK-2599 | None | None | None |