AZD2171 and Whole Brain Radiation Therapy (WBRT) in Patients With Brain Metastases
Status: | Archived |
---|---|
Conditions: | Breast Cancer, Lung Cancer, Colorectal Cancer, Skin Cancer, Cancer, Cancer, Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | September 2009 |
End Date: | July 2011 |
A Phase I Study of AZD2171 and WBRT in Patients With Brain Metastases
In this research study the investigators are looking for the highest dose of AZD2171 that
can be given safely to participants with brain metastases who are being treated with whole
brain radiation. The investigators also want to see what side effects participants
experience when taking AZD2171. The researchers are looking at the effect of this drug on
the participants's tumor size and disease progression. This drug works by interfering with
(or inhibiting) a substance called VEGF (Vascular Endothelial Growth Factor). VEGF helps
tumors grow and survive by supporting the growth of the blood vessels that bring nutrients
to the tumor. When the activity of VEGF is interrupted, the blood vessels around the tumor
cells die. The tumors may then die because nutrients aren't getting to the tumor.
- Since we are looking for the highest dose of the study drug that can be administered
safely without severe or unmanageable side effects, not everyone who participates in
this research study will receive the same dose of the study drug. The dose will depend
on the number of participants who have been enrolled in the study and how well the dose
has been tolerated.
- AZD2171 is taken orally once a day and participants will begin taking the study drug 2
days before the start of whole brain radiation.
- For the first 3 weeks of the study, participants will be treated with radiation therapy
to the whole brain. They will be receiving radiation therapy at the same time as they
are taking study drug. When radiation is complete, they will continue to take the
study drug daily without interruption.
- Each 28 day period that participants take study drug is called a cycle of study
treatment.
- Participants will be required to monitor their blood pressure regularly. They will be
given blood pressure monitoring equipment and be asked to record their blood pressure
readings twice a day.
- The following tests and procedures will be done within one week before the start of
every 4-week cycle: Medical history; physical exam; vital signs; assessment of the
tumor by MRI or CT; blood tests, EKG test and urine test.
- As part of this study, participants will have special types of MRI studies called
"Vascular MRIs". These are research MRIs designed to monitor the blood supply to the
tumor and brain. The first Vascular MRI will be done between 1 and 5 days before
participants begin treatment. An additional scan will be obtained 24 hours after the
first dose of study drug but before the second dose. Vascular MRIs will also be done
on days 21 and 49 of the study, and then once every other cycle going forward (every 56
days).
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