Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450515
Status:
WITHDRAWN
Last Update Posted:
2016-12-06
First Post:
2007-03-20
Brief Title:
Vinflunine and Capecitabine in Treating Patients With Previously Treated Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was dropped prior to opening
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 such as vinflunine and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving vinflunine together with capecitabine works in treating patients with previously treated metastatic breast cancer
PURPOSE This phase II trial is studying how well giving vinflunine together with capecitabine works in treating patients with previously treated metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the tumor response rate in patients with previously treated metastatic breast cancer treated with vinflunine and capecitabine
Secondary
Describe the adverse event profile of this regimen in these patients
Determine the progression-free survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the duration of response in patients treated with this regimen
Determine the time to treatment failure in patients treated with this regimen
Describe the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every other course and at the completion of study treatment
After completion of study treatment patients are followed periodically for up to 5 years
Primary
Evaluate the tumor response rate in patients with previously treated metastatic breast cancer treated with vinflunine and capecitabine
Secondary
Describe the adverse event profile of this regimen in these patients
Determine the progression-free survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the duration of response in patients treated with this regimen
Determine the time to treatment failure in patients treated with this regimen
Describe the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every other course and at the completion of study treatment
After completion of study treatment patients are followed periodically for up to 5 years
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 |
|---|---|---|---|
| CDR0000536545 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2011-01743 | REGISTRY | None | None |