Phase I Trial of Sunitinib Plus Temsirolimus in Patients With Metastatic Renal Cell Cancer
The Study Drugs:
Sunitinib is designed to block pathways that control important events (such as the growth of
blood vessels) that are essential for the growth of cancer.
Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells
to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of the combination of sunitinib and temsirolimus based on when you joined this study.
There will be 2 stages in this study.
Up to 5 dose levels of the study drug combination will be tested in Stage 1. Two (2)
participants will be enrolled at each dose level. The first group of participants will
receive the lowest dose level. Each new group will receive a higher dose than the group
before it, if no intolerable side effects were seen. This will continue until the highest
tolerable dose of the study drug combination is found.
During Stage 2, different doses of the individual study drugs will be tested based on the
highest tolerable combination dose that was found in Stage 1.
Study Drug Administration:
During each 3-week "study cycle," you will take sunitinib 1 time each day (either with or
without food) for 2 weeks followed by 1 week of rest with no study drug.
You will receive temsirolimus by vein 1 time every week over 30-60 minutes. About 30
minutes before you receive temsirolimus, you will receive Benadryl (diphenhydramine) by vein
over 30 minutes to help prevent side effects.
If you have any side effects from any of the drugs, tell the study doctor right away. The
study doctor may then lower the dose or keep the dose level the same.
Study Visits:
Every week (right before you receive temsirolimus), blood (about 2 teaspoons) will be drawn
for routine tests.
On Day 1 of every cycle:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any drugs or treatments you may be receiving.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests (in addition to the weekly
blood draw described above).
Every 6 weeks:
- You will have the same imaging scans (CT and/or MRI scan) that you had at the screening
visit. If you have stable disease after 2 scans, you will have these every 12 weeks.
- Blood (about 2 teaspoons) will be drawn to check your thyroid function.
- Urine will be collected for routine tests.
Blood Pressure Monitoring:
During the first 3 weeks of the study, your blood pressure will be checked weekly. This may
be done at your local doctor's office. You should write down your blood pressure each time
it is checked in a blood pressure journal that the study staff will give you and bring it
with you when you see your doctor.
Length of Study:
You will remain on study for as long as you are benefiting. You will be taken off study if
the disease gets worse or if you have intolerable side effects.
End-of-Study Visit:
After the last dose of study drug, you will have an end-of-study visit. At the end-of-study
visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any drugs or treatments you may be receiving.
- You will be asked about any side effects you may have experienced since your last
visit.
This is an investigational study. Sunitinib and temsirolimus are both FDA approved and
commercially available for the treatment of advanced kidney cancer. The use of the drugs in
combination is investigational.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
3 week cycles
No
Nizar M. Tannir, MD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0037
NCT01122615
May 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |