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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00828074 |
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 vinorelbine, 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 vinorelbine may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when given together with vinorelbine and to see how well they work in treating women with stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: sorafenib tosylate Drug: vinorelbine ditartrate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Vinorelbine and Sorafenib as Salvage Therapy in Metastatic Breast Cancer |
Estimated Enrollment: | 47 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of sorafenib tosylate followed by a phase II study.
Patients receive oral sorafenib tosylate on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
No known brain metastases
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
City of Hope Medical Group | Recruiting |
Pasadena, California, United States, 91105 | |
Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com |
Principal Investigator: | Thehang H. Luu, MD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( Thehang H. Luu ) |
Study ID Numbers: | CDR0000632806, CHNMC-08103, BAYER-CHNMC-08103 |
Study First Received: | January 22, 2009 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00828074 History of Changes |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer |
Vinorelbine Skin Diseases Tubulin Modulators Breast Neoplasms Vinblastine Antimitotic Agents |
Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic Sorafenib Breast Diseases Recurrence |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Mitosis Modulators Breast Neoplasms Enzyme Inhibitors Vinblastine Antimitotic Agents Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Vinorelbine Therapeutic Uses Tubulin Modulators Sorafenib Antineoplastic Agents, Phytogenic Breast Diseases |