A Phase II Study of the Combination of Bevacizumab and Erlotinib in Patients With Unresectable Hepatocellular Carcinoma
Liver cancer growth may be affected by a protein in the body called "vascular epidermal
growth factor" (VEGF). A drug that blocks VEGF may be an effective treatment for liver
cancer. Avastin is designed to block VEGF. Erlotinib hydrochloride is an investigational
drug believed to work on cancer cells by affecting epidermal growth factor receptor (EGFR),
a protein that is important to cancer growth.
If the screening evaluations show you are eligible to take part in the study, you may begin
treatment. You will receive treatment in 28-day periods called "cycles". Treatment will be
given on an outpatient basis. Because this is a research study, the Avastin infusion must
be given every time at M. D. Anderson. Because erlotinib hydrochloride is given by mouth,
you may take it away from M. D. Anderson.
You will receive Avastin through a needle in a vein on Days 1 and 15 of each cycle. The
first dose of Avastin will be given over about 90 minutes. If you do not have a reaction
(such as fever/chills), the next dose will be given over about 60 minutes. If again no
reaction occurs, each dose after that will be given over about 30 minutes. If you
experience a reaction to the Avastin infusion, you may be given acetaminophen (such as
Tylenol) by mouth and/or an antihistamine by vein over 30 minutes before each dose to help
decrease the risk of further reactions.
You will take erlotinib hydrochloride tablets by mouth every day. It is recommended that
erlotinib hydrochloride be taken in the morning with a glass of water. Erlotinib
hydrochloride should be taken at least 1 hour before or 2 hours after you have any food,
grapefruit juice, vitamins, iron supplements, or other non-prescription medicines.
Before each new cycle of study treatment, you will have urine collected, and blood will be
drawn (about 3 tablespoons) for routine blood tests and to check your blood clotting. You
will be asked questions about any side effects you may have had and about any medications
you are currently taking or have taken since you last saw the study doctor. You will have a
complete physical exam, including measurements of vital signs and weight. You will be asked
about your ability to perform everyday tasks.
You will also have CT and/or MRI scans of the tumor(s) every 8 weeks. Additional tests may
be done during the study if your doctor feels it is necessary for your care. All testing
and evaluations must be done at M. D. Anderson.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive
smaller doses of the treatment. You may continue to receive study treatment unless the
disease gets worse, the side effects are too severe, you decide not to take part any longer,
or your doctor decides it is in your best interest to stop treatment. There is no maximum
number of cycles that you can receive.
When you stop study treatment, you will be asked to have tests and evaluations done at an
end-of-study visit. You will have urine collected, and blood will be drawn (about 3
tablespoons) for routine blood tests and to check your blood clotting. You will be asked
questions about any side effects you may have had and about any medications you are
currently taking or have taken since you last saw the study doctor. You will have a complete
physical exam, including measurements of blood pressure, pulse, temperature, and weight.
You will be asked about your ability to perform everyday tasks. You will also have CT
and/or MRI scans of the abdomen and pelvis to check on your cancer.
Once you stop receiving study treatment, the study doctor or nurse will continue to check
how you are doing, either in the clinic or by telephone if you stop coming to M. D.
Anderson, every 3 months for the rest of your life.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for
treatment of lung cancer, but it is not approved for liver cancer, so its use is considered
experimental in this study. Avastin is approved by the FDA for treatment of colon and
rectal cancer, but it is not approved for the treatment of liver cancer, so its use is
considered experimental in this study. Up to 60 participants will take part in this study.
All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS) Rate
Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Baseline to 16 weeks
Ahmed Kaseb, M.D.
M.D. Anderson Cancer Center
United States: Institutional Review Board
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