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Sponsors and Collaborators: |
Dana-Farber Cancer Institute AstraZeneca Massachusetts General Hospital Brigham and Women's Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00496665 |
The purpose of this research study is to determine the safety and tolerability of the combination of Zactima with metronomic chemotherapy. Zactima is an oral anti-angiogenesis drug, which means it fights cancer by cutting off a tumor's blood supply. Thus, the drug starves the tumor by preventing the delivery of nutrients and oxygen. Metronomic chemotherapy is low dose oral chemotherapy pills which are taken daily. Unlike traditional chemotherapy, metronomic chemotherapy is thought to fight cancer like Zactima, by cutting off the blood supply to tumors. Because the dose is very low, the side effects are generally mild and very different from those with higher dose chemotherapy given by vein.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: ZD6474 Drug: Cyclophosphamide Drug: Methotrexate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of ZD6474 (Zactima) and Metronomic Chemotherapy in Advanced Breast Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erica Mayer, MD, MPH | 617-632-3800 | emayer@partners.org |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Erica Mayer, MD, MPH | |
Principal Investigator: Harold Burstein, MD, PhD | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Principal Investigator: Steven Isakoff, MD, PhD |
Principal Investigator: | Erica Mayer, MD, MPH | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Erica Mayer, MD ) |
Study ID Numbers: | 06-402 |
Study First Received: | July 3, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00496665 |
Health Authority: | United States: Food and Drug Administration |
Stage IV breast cancer metronomic chemotherapy |
Folic Acid Skin Diseases Methotrexate |
Breast Neoplasms Cyclophosphamide Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |