Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer
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, which 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 erlotinib
hydrochloride by mouth every day of each 28-day study "cycle". You should take erlotinib
hydrochloride once a day in the morning with 1 cup (about 8 oz.) of water. Erlotinib
hydrochloride should be taken at least 1 hour before or 2 hours after you have any food,
vitamins, iron supplements, or other non-prescription drugs.
On Days 1, 8, 15, and 22 of each cycle, you will take RAD001 by mouth in the morning. You
should either take the study drug on an empty stomach with 2 cups (about 16 oz.) of water or
after a low-fat meal. You should not take the study drug after large fatty meals because
fatty meals lower the amount of the study drug in your body. Some examples of a low-fat meal
include cereal with fat-free milk, a low-fat muffin, toast, or a bagel with fat-free spread,
or fruit salad.
On days when you take both RAD001 and erlotinib hydrochloride, RAD001 should be taken right
before erlotinib hydrochloride.
If you experience intolerable side effects, you must call your doctor right away. The doctor
may tell you to stop taking the study drugs or to take fewer pills. The study drugs may also
be stopped completely, if your doctor thinks it is necessary.
Study Visits:
On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a performance status evaluation.
- Blood (about 2 tablespoons) and urine will for collected for routine tests. You should
be fasting at the time of the blood draw. You should not eat or drink anything except
water after midnight the night before.
- You will be asked about any drugs you may be taking or have taken since your last
visit.
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 tablespoons) and urine will be collected for routine tests. You should
be fasting at the time of the blood draw. You should not eat or drink anything except
water after midnight the night before.
- You will be asked about any drugs you may be taking or have taken since your last
visit.
At the end of every even cycle (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan
to check the status of the disease. The scans will be the same type that you had during
screening.
Length of Study:
You may remain on study as long as you are benefitting. You will be taken off study early if
the disease gets worse, you have intolerable side effects, or if your doctor decides that it
is in your best interest to stop treatment.
End-of-Study Visit:
About 14 days after the last dose of study drug, you will have an end-of-study visit. The
following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a performance status evaluation.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests. You should
be fasting at the time of the blood draw. You should not eat or drink anything except
water after midnight the night before.
- If you have not had them within the last 4 weeks, you will have a CT or MRI scan to
check the status of the disease. The scans will be the same type that you had during
screening.
Long-Term Follow-Up:
After you go off study, you will be asked how you are doing once a month for the first 6
months from the beginning of the study treatment. Then you will be asked how you are doing
every 3 months from then on. This may be done either by phone contact or a clinic visit and
will take about 15-30 minutes.
This is an investigational study. Erlotinib hydrochloride in combination with gemcitabine
is commercially available and FDA approved for the treatment of pancreatic cancer. RAD001
is not FDA approved or commercially available. At this time, the combination of these drugs
is only being used in research.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Surviving at 6 Months
Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.
6 months
No
Milind Javle, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
2007-0666
NCT00640978
March 2008
March 2010
Name | Location |
---|---|
U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |