Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049660
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2002-11-12
Brief Title:
Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer
PURPOSE Randomized phase IIIII trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy
PURPOSE Randomized phase IIIII trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy
Detailed Description:
OBJECTIVES Phase II Study
Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine
Compare the duration of response in patients treated with these drugs
Phase III Study
Compare overall and progression-free survival in patients treated with these drugs
Compare time to treatment failure in patients treated with these drugs
Compare overall safety of these drugs in these patients
Compare quality of life and clinical benefit response in patients treated with these drugs
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and taxane resistance refractory vs resistant vs sensitive
Phase II Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive vinorelbine IV on days 1 and 8 Courses repeat every 21 days
Arm II Patients receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days
In both arms treatment continues in the absence of progression or unacceptable toxicity
If sufficient response rate is determined in phase II the phase III study is initiated
Phase III Patients are randomized and receive treatment as in phase II Quality of life is assessed prior to randomization at weeks 3 6 9 18 24 and 30 and then every 12 weeks until disease progression
Clinical benefit response is assessed daily while patient is on study
Patients are followed every 6 weeks until disease progression and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 72 patients 36 per treatment arm will be accrued for phase II of this study and a total of 406-452 patients 203-226 per treatment arm will be accrued for phase III of this study within 185 months
Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine
Compare the duration of response in patients treated with these drugs
Phase III Study
Compare overall and progression-free survival in patients treated with these drugs
Compare time to treatment failure in patients treated with these drugs
Compare overall safety of these drugs in these patients
Compare quality of life and clinical benefit response in patients treated with these drugs
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and taxane resistance refractory vs resistant vs sensitive
Phase II Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive vinorelbine IV on days 1 and 8 Courses repeat every 21 days
Arm II Patients receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days
In both arms treatment continues in the absence of progression or unacceptable toxicity
If sufficient response rate is determined in phase II the phase III study is initiated
Phase III Patients are randomized and receive treatment as in phase II Quality of life is assessed prior to randomization at weeks 3 6 9 18 24 and 30 and then every 12 weeks until disease progression
Clinical benefit response is assessed daily while patient is on study
Patients are followed every 6 weeks until disease progression and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 72 patients 36 per treatment arm will be accrued for phase II of this study and a total of 406-452 patients 203-226 per treatment arm will be accrued for phase III of this study within 185 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 |
|---|---|---|---|
| IDBBC-EORTC-10001 | None | None | None |
| EORTC-10001 | None | None | None |
| EORTC-16001O | None | None | None |