ZD6474 (Zactima) and Metronomic Chemotherapy in Advanced Breast Cancer
NCT00496665 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2013-11-18
Summary
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.
Conditions
Interventions
- DRUG
-
Vandetanib
Taken orally once a day in 28-day cycles (the dose will vary)
- DRUG
-
Metronic Chemotherapy: Low dose pills taken every day of each 28-day cycle
- DRUG
-
Methotrexate
Metronic Chemotherapy: low dose pills taken on days 1 and 2 of each week
Sponsors & Collaborators
- collaborator INDUSTRY
-
Massachusetts General Hospital
collaborator OTHER -
Brigham and Women's Hospital
collaborator OTHER - lead OTHER
Principal Investigators
-
Erica Mayer, MD, MPH · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2008-08-31
- Completion
- 2009-03-31
Countries
- United States
Study Locations
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