Phase II Clinical Trial of the Combination of RAD001 and Erlotinib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
The Study Drugs:
RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of
new blood vessels that help tumor growth, and this may cause the tumor cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface
of many tumor cells that may control tumor growth and survival. This may stop tumors from
growing.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 1 RAD001 tablet
and 1 erlotinib hydrochloride tablet every day of each 28 day study "cycle".
Both drugs should be taken at the same time, by mouth, with a cup (8 ounces) of water. You
should take the drugs at least 1 hour before or 2 hours after eating. You should take the
study drugs at around the same time each day. Your eating habits around the time you take
the drugs should stay the same while you are on study. lf you vomit, you should not take
another tablet until your next scheduled dose.
Tell your doctor if you have any side effects, as your dose(s) of study drug(s) may be
lowered or stopped for a few days. You may be given drugs to help reduce the risk of side
effects.
Study Visits:
On Day 1 (+/- 3 days) of each cycle, the following tests and procedures will be performed:
- You will have a complete physical exam, including measurement of your weight and vital
signs.
- You will be asked about any drugs you may be taking and any side effects you may be
having.
- Your performance status will be recorded.
- Blood (about 3 teaspoons) will be drawn for routine tests. If your doctor thinks it is
needed, you may have to have these blood tests more often.
On Day 1 (+/- 3 days) of every evenly numbered cycle (Cycles 2, 4, 6, and so on), you will
have a CT scan or MRI scan to check the status of the disease.
Length of Study:
You may continue to take the study drugs for as long as you are benefitting. You will be
taken off study if the disease gets worse or if you have intolerable side effects.
End-of-Study Visit:
When you go off study for any reason, you will have an end-of-study visit. The following
tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a complete physical exam, including measurement of your weight and vital
signs.
- You will be asked about any drugs you may be taking and any side effects you may be
having.
- Your performance status will be recorded.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- You will have a CT scan or MRI scan to check the status of the disease.
Follow-Up:
You will be called within 30 days after the end-of-study visit and asked how you are doing
and about any possible side effects that you may have had. The call should take about 5
minutes.
This is an investigational study. RAD001 is FDA approved and commercially available for the
treatment of certain types of breast cancer. Erlotinib hydrochloride is FDA approved and
commercially available for the treatment of advanced non-small cell lung carcinoma (NSCLC)
and advanced pancreatic cancer. The use of this drug combination for the treatment of HNSCC
is investigational.
Up to 35 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
Tumor Response Rate
After 4 weeks of treatment, after 12 weeks after treatment, then every 8 weeks thereafter. Tumor assessments performed by CT scan or MRI throughout the study.
Every 8 weeks
No
Vali Papadimitrakopoulou, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2008-0567
NCT00942734
July 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |