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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00616122 |
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib when given together with cyclophosphamide and methotrexate to see how well they work in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: cyclophosphamide Drug: methotrexate Drug: sunitinib malate Procedure: laboratory biomarker analysis |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase I/II Study of SU11248 (Sutent) in Combination With Metronomic Dosing of Cyclophosphamide and Methotrexate in Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 56 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of sunitinib malate.
NOTE: *Course 1 includes 2 weeks of sunitinib malate alone followed by sunitinib malate, cyclophosphamide, and methotrexate for 21 days
Blood samples are collected periodically for measurement of circulating tumor cells, circulating endothelial cells, and VEGF levels.
After completion of study treatment, patients are followed for 30 days and then every 2 months for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of breast cancer with documented progressive disease
Must have received at least one prior chemotherapy regimen for metastatic breast cancer
PATIENT CHARACTERISTICS:
No severe concurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 |
Principal Investigator: | Hope S. Rugo, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000583268, UCSF-057519 |
Study First Received: | February 14, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00616122 |
Health Authority: | Unspecified |
recurrent breast cancer stage IV breast cancer male breast cancer |
Folic Acid Skin Diseases Breast Neoplasms, Male Sunitinib Methotrexate |
Breast Neoplasms Cyclophosphamide Breast Diseases Recurrence |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Neoplasms by Site Therapeutic Uses Abortifacient Agents Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Growth Substances Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |