Phase I Study of Temsirolimus in Combination With Metformin in Patients With Advanced Cancers
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of temsirolimus and metformin based on when you join this study. Up to 6 dose levels
of temsirolimus and metformin will be tested. Up to 6 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 combination of
temsirolimus and metformin is found.
When the highest tolerable dose or most appropriate combination dose level is found, 14 more
participants will take the study drugs at this dose level.
Study Drug Administration:
Each study cycle is 28 days. Before you start taking both drugs in Cycle 1, you will take
metformin only for 2 weeks. This is called a titration period.
On Days 1, 8, 15, and 21 of each cycle, you will receive temsirolimus by vein over 30-60
minutes.
Before you receive temsirolimus, you will receive Benadryl (diphenhydramine) by vein over
30-60 minutes to help lower the risk of allergic reactions.
You will take metformin by mouth every day at about the same time each day with a meal and
cup of water (about 8 ounces). You should take it at home except on the days when you have a
study visit. Depending on your dose, you may take metformin 1-3times daily. Your study
doctor will tell you how to take this drug.
You will be given a letter to take to your home doctor(s) about your study drug
administration as part of your care provided outside of MD Anderson.
Study Visits:
At every study visit, you will be asked about your health, any other drugs you are taking,
and if you have had any side effects.
Exams and tests will be performed before you receive the study drugs that day. Cycle 1 Week
1 tests and exams may not have to be repeated if done within 7 days.
During Week 1 of the titration period:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- During Week 1 only, urine will be collected for routine tests.
During Week 2 of the titration period:
-Blood (about 2 teaspoons) will be drawn for routine tests.
During Weeks 1 and 3 of Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- During Week 1 only, urine will be collected for routine tests.
During Weeks 2 and 4 of Cycle 1, blood (about 2 teaspoons) will be drawn for routine tests.
During Week 1 of Cycles 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
During Week 3 of Cycles 2 and beyond, blood (about 2 teaspoons) will be drawn for routine
tests.
About every 8 weeks, you will have an x-ray, CT scan, MRI scan, and/or PET/CT scan to check
the status of the disease. If the study doctor thinks it is needed, they will be performed
more often.
After about 6 months (about 6 cycles) of taking the study drugs, you will have the CT scan
or MRI scan every 2-4 cycles if your study doctor thinks it is needed.
Length of Study Participation:
You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over when you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of study drugs, you will return to the clinic. The
following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
This is an investigational study. Temsirolimus is FDA approved and commercially available
for the treatment of renal cell carcinoma. Metformin is FDA approved and commercially
available for the treatment of diabetes mellitus. The combination of these drugs to treat
advanced cancer is investigational.
Up to 64 patients will take part in this study. All 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) of Temsirolimus and Metformin
MTD defined as highest dose studied in which incidence of dose limiting toxicity (DLT) less than 33%. DLTs defined as adverse events (AEs) related to study agents which occur during first cycle of treatment. Toxicity must have possible, probable or definite attribution to study drugs.
10 weeks
Yes
Aung Naing, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2011-0923
NCT01529593
March 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |