Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT00049660
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2002-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
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 II/III 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 II/III 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 18.5 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 18.5 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: