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Sponsored by: |
Simmons Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00622466 |
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 | Intervention | Phase |
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Breast Cancer |
Drug: paclitaxel Drug: sorafenib tosylate Genetic: gene expression analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer |
Estimated Enrollment: | 41 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxil 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically* confirmed breast cancer
Stage IV (metastatic) disease
Measurable disease by RECIST criteria defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (i.e., physical examination, CT scan, MRI, or x-ray) or ≥ 10 mm by spiral CT scan
Primary tumor or metastatic tumor HER2-negative, defined as the following:
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Active or uncontrolled medical illness (e.g., active infection > CTCAE grade 2), including any of the following:
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior hormonal therapy for MBC or adjuvant or neoadjuvant chemotherapy
United States, Texas | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 |
Principal Investigator: | Barbara B. Haley, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000587470, SCCC-112007-035, ONYX-SCCC-112007-035, SCCC-02107 |
Study First Received: | February 22, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00622466 History of Changes |
Health Authority: | Unspecified |
stage IV breast cancer male breast cancer recurrent breast cancer HER2-negative breast cancer |
Skin Diseases Breast Neoplasms, Male Paclitaxel Tubulin Modulators Breast Neoplasms Antimitotic Agents |
Breast Cancer, Male Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic Sorafenib Breast Diseases Recurrence |
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Breast Neoplasms Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Sorafenib Antineoplastic Agents, Phytogenic Breast Diseases |