A Phase II Trial of Erlotinib Plus Bevacizumab in Advanced Hepatocellular Carcinoma as a Second-line Therapy in Patients Who Have Received First-line Sorafenib Therapy (AVF4572)
The Study Drugs:
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary
for tumor growth. This may prevent or slow down the growth of cancer cells.
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. There is a commercially available form of the drug (called Tarceva) that is
expected to be very similar to the erlotinib being used for this study, but it is possible
that there may be some differences between the 2 formulations.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drugs
during 28-day "study cycles."
You will receive bevacizumab by vein on Days 1 and 15 of each cycle. The first dose of
bevacizumab will be given over about 90 minutes. If you do not have a reaction to the drug,
such as fever and/or chills, the next dose will be given over about 60 minutes. If you
still have no reaction after the second dose, each dose after that will be given over about
30 minutes. If you experience a reaction to the bevacizumab, you may be given Tylenol®
(acetaminophen) by mouth and/or an antihistamine by vein over 30 minutes before each dose to
help minimize the risk of further reactions.
You will take 1 erlotinib hydrochloride tablet by mouth every day. You should take
erlotinib hydrochloride in the morning with a full glass of water (6-8oz) at least 1 hour
before or 2 hours after any food, grapefruit juice, vitamins, iron supplements, or other
non-prescription drugs.
Study Visits:
On Day 1 of Cycle 2 and beyond:
- Blood (about 3 tablespoons) will be drawn for routine blood tests and to check how well
the blood clots.
- Urine will be collected for routine testing. A 24-hour urine sample may be collected
if needed. If a 24-hour urine sample is needed, you will be provided with a special
container to collect the sample.
- You will be asked questions about any side effects you may have had and about any drugs
you may be currently taking or have taken since you last saw the study doctor.
- You will have a complete physical exam, including measurements of weight and vital
signs.
- Your performance status will be recorded.
On Day 15 of Cycle 2 and beyond, your vital signs will be recorded.
At the end of Cycle 2, 4, and every 2 cycles after that (Cycles 6, 8, 10, and so on):
-You will have CT/MRI scans of the abdomen and pelvis and chest scan (if the doctor thinks
they are needed) to check the status of the disease.
Additional tests may be done during the study if the study doctor thinks it is necessary.
Length of Treatment:
You will receive bevacizumab and erlotinib hydrochloride for as long as you are benefitting.
There is no maximum number of cycles that you can receive. If you experience severe side
effects, the treatment on this study may be delayed, stopped, or the study doctor may give
you smaller doses of the study drugs. You will be taken off study if the disease gets
worse, the side effects are too severe, or your doctor thinks that it is in your best
interest to stop receiving treatment.
End-of-Treatment Visit:
After you stop receiving all of the study drugs, you will return for an end-of-treatment
visit. At this visit, the following tests and procedures will be performed:
- Blood (about 3 tablespoons) and urine will be collected for routine tests and to learn
how well the blood clots.
- You will be asked questions about any side effects you may have had and about any drugs
you may be currently taking or have taken since you last saw the study doctor.
- You will have a complete physical exam, including measurements of weight and vital
signs.
- Your performance status will be recorded.
- CT and/or MRI scans of the abdomen and pelvis will be performed to check the status of
the disease.
Follow-Up:
After the end-of-treatment visit, the study doctor will continue to review your medical
records every 3 months until the study analysis is complete. You will also be called every
3 months for as long as the study doctor thinks is needed. During these phone calls, you
will be asked about how you are doing and if you are experiencing any health problems. The
phone call should take about 15 minutes. During the follow-up period, if the study doctor
thinks it is necessary, you may be asked to come in for a clinic visit.
This is an investigational study. Bevacizumab is FDA approved and commercially available
for the treatment of metastatic colon and rectal cancer. Erlotinib hydrochloride is FDA
approved and commercially available for the treatment of lung cancer. The use of this drug
combination in patients with advanced liver cancer is investigational.
Up to 44 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Progression Free Survival (PFS) at 16 weeks
Progression-free survival is defined as time from initiation of therapy until documented disease progression or death.
16 weeks
No
Ahmed Kaseb, MBBS
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2009-0260
NCT01180959
April 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |