Phase I/II Study of Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
The Study Drugs:
Zoledronic acid is designed to strengthen the bone and prevent fractures or breaks in the
bone. Dasatinib is designed to block (stop) cells responsible for the breakdown of bone.
Study Groups:
If you are found to be eligible to take part in this study, you will be enrolled in a group
of at least 3 participants to begin receiving zoledronic acid and dasatinib. The dose of
dasatinib you receive will depend on when you enrolled in this study. All participants will
receive the same amount of zoledronic acid. The first group of participants will be treated
with the lowest dose of dasatinib given in combination with zoledronic acid.
Once the highest tolerable dose level is found, up to 25 additional participants will be
enrolled at that dose level. This is called the Phase II portion of the study.
Drug Administration:
You will receive zoledronic acid through a needle in your vein on Day 1 over 15 minutes. You
will take dasatinib by mouth daily for 28 days. Dasatinib should be taken on an empty
stomach or after a light meal. Every 28 days is called a study "cycle."
Study Visits for Participants in the Phase I Portion:
On Day 1 of Cycle 1, you will have the following tests and procedures performed.
- You will have a physical exam, including measurement of your vital signs.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 8 of Cycle 1, you will have the following tests and procedures performed.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 15 of Cycle 1, you will have the following tests and procedures performed.
- You will have a physical exam.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 21 of Cycle 1, you will have the following tests and procedures performed.
- Your vital signs will be measured.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have an ECG.
On Day 1 of Cycle 2, you will have an ECG.
On Day 1 of all other cycles, you will have the following tests and procedures performed.
- You will have a physical exam.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected over 24 hours
to check for markers of bone loss.
After Cycles 3, 6, 9 and so on, you will have CT scans, MRIs, and/or x-rays to check the
status of the disease
At all study visits, you will be asked about any drugs you may be taking and any side
effects you may be experiencing.
Study Visits for Participants in the Phase II Portion:
On Day 1 of all cycles, you will have the following tests and procedures performed.
- You will have a physical exam, including measurement of your vital signs.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected to check for
markers of bone loss.
After Cycles 2, 4, 6 and so on, you will have CT scans, MRIs, and/or x-rays to check the
status of the disease.
At all study visits, you will be asked about any drugs you may be taking and any side
effects you may be experiencing.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study if
the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
Once you go off-study, you will have an end-of-study visit.
- Your vital signs will be measured.
- Blood (about 1-2 teaspoons) and urine will be collected for routine tests.
- You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
This is an investigational study. Zoledronic acid is FDA approved and commercially
available for the treatment of breast cancer. Dasatinib is not FDA approved or commercially
available for the treatment of breast cancer. It has been authorized for use in research
only. Up to 28 patients will take part in this multicenter study. Up to 12 will be
enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Continous reassessment with each dose level (28 day cycle)
Yes
Stacy Moulder, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2006-0900
NCT00566618
November 2007
Name | Location |
---|---|
Duke University | Durham, North Carolina 27710 |
University of Chicago | Chicago, Illinois 60637 |
UT MD Anderson Cancer Center | Houston, Texas 77030 |