Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer|
- Response rate [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- 6-month progression-free survival [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Clinical benefit rate (tumor and stable disease) at 24 weeks [ Time Frame: 24 weeks from patient start of treatment ] [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Relationship of gene expression and tissue/serum protein markers related to response to therapy focusing on growth factor receptor pathways [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622466
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Barbara B. Haley, MD||Simmons Cancer Center|