Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00622466|
Recruitment Status : Unknown
Verified May 2015 by University of Texas Southwestern Medical Center.
Recruitment status was: Active, not recruiting
First Posted : February 25, 2008
Last Update Posted : June 1, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: paclitaxel Drug: sorafenib tosylate||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
U.S. FDA Resources
Experimental: Sorfenib + Paclitaxel
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
Other Name: Taxol, Abraxane, OnxolDrug: sorafenib tosylate
Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
Other Name: Nexavar
- Response rate
- Time to disease progression
- 6-month progression-free survival
- Time to treatment failure
- Clinical benefit rate (tumor and stable disease) at 24 weeks [ Time Frame: 24 weeks from patient start of treatment ]
- Duration of response
- Relationship of gene expression and tissue/serum protein markers related to response to therapy focusing on growth factor receptor pathways
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622466
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Barbara B. Haley, MD||Simmons Cancer Center|