A Phase I Study of ZD6474 (Zactima) and Metronomic Chemotherapy in Advanced Breast Cancer
- Each study cycle is 28 days long. Participants will take the study drug, Zactima, by
mouth once a day. The dose of Zactima the participant will receive will be determined
by the time when they enroll on the study. They will also take the metronomic
chemotherapy by mouth. This consists of two drugs: cyclophosphamide and methotrexate.
Cyclophosphamide is taken every day and methotrexate is taken on days 1 and 2 of each
- A physical exam will be performed on Day 1 of each cycle. Vital signs, including
height, weight, blood pressure, and temperature will be done on Day 1 of each cycle, as
well as at week 3 of Cycles 1 and 2.
- Electrocardiograms will be performed at various points to assess heart function. This
will be done at week 1, 3, 5, 7, and 9, and then every 3 months for the rest of the
- Routine blood tests will be done on Day 1 of each cycle, as well as at week 3 for the
first two cycles. Urine tests will be done on Day 1 of each cycle.
- An ultrasound will be done at Brigham and Women's Hospital in the Department of
Vascular Medicine at week 3 and week 7.
- Participants will have scans done to assess their tumor every 2 cycles (8 weeks).
These may include a CT scan, MRI, PET scan, x-rays, and/or bone scans.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and tolerability of combination therapy with ZD6474 (Zactima) and metronomic chemotherapy
Erica Mayer, MD, MPH
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|