ZD6474 (Zactima) and Metronomic Chemotherapy in Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00496665|
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : November 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Vandetanib Drug: Cyclophosphamide Drug: Methotrexate||Phase 1|
- 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 week.
- 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 study.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of ZD6474 (Zactima) and Metronomic Chemotherapy in Advanced Breast Cancer|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||March 2009|
Cyclophosphamide 50 mg daily, methotrexate 2.5 mg days 1-2 weekly, and daily vandetanib (zactima) in 3 dose-escalation cohorts (100mg=Cohort 1) (200mg=Cohort 2) (300mg=Cohort3)
Taken orally once a day in 28-day cycles (the dose will vary)
Other Names:Drug: Cyclophosphamide
Metronic Chemotherapy: Low dose pills taken every day of each 28-day cycleDrug: Methotrexate
Metronic Chemotherapy: low dose pills taken on days 1 and 2 of each week
- To determine the safety and tolerability of combination therapy with ZD6474 (Zactima) and metronomic chemotherapy [ Time Frame: 2 years ]
- To determine the response rate of combination therapy with ZD6474 (Zactima) and metronomic chemotherapy in patients with measurable disease. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496665
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Erica Mayer, MD, MPH||Dana-Farber Cancer Institute|