Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-04 @ 1:06 AM
Study NCT ID:
NCT00622466
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2008-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Phase II Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study sponsor requested that the study be permanently closed by letter.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* To evaluate the efficacy of sorafenib tosylate and paclitaxel by measuring tumor response, as defined by RECIST criteria, in patients with metastatic, HER2-negative breast cancer.
Secondary
* To evaluate time to disease progression in patients treated with this regimen.
* To evaluate six-month progression-free survival of patients treated with this regimen.
* To evaluate time to treatment failure in patients treated with this regimen.
* To evaluate clinical benefit rate (tumor response and stable disease) at 24 weeks in patients treated with this regimen.
* To evaluate duration of response in patients treated with this regimen.
* To evaluate the tolerability of this regimen in these patients.
* To examine the relationship of gene expression and tissue/serum protein markers, where available, related to response to therapy focusing on growth factor receptor pathways.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks.
Primary
* To evaluate the efficacy of sorafenib tosylate and paclitaxel by measuring tumor response, as defined by RECIST criteria, in patients with metastatic, HER2-negative breast cancer.
Secondary
* To evaluate time to disease progression in patients treated with this regimen.
* To evaluate six-month progression-free survival of patients treated with this regimen.
* To evaluate time to treatment failure in patients treated with this regimen.
* To evaluate clinical benefit rate (tumor response and stable disease) at 24 weeks in patients treated with this regimen.
* To evaluate duration of response in patients treated with this regimen.
* To evaluate the tolerability of this regimen in these patients.
* To examine the relationship of gene expression and tissue/serum protein markers, where available, related to response to therapy focusing on growth factor receptor pathways.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks.
Study Oversight
Has Oversight DMC:
True
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?: