Clinical trial NCT00242502
Conditions: Hepatocellular Carcinoma Liver Cancer
Keywords: Hepatocellular Carcinoma Liver Cancer Bevacizumab Anti-VEGF monoclonal antibody rhuMAb-VEGF Erlotinib Hydrochloride OSI-774 Tarceva Erlotinib Avastin
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-10-01; Completion date: 2011-10-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks following initiation of therapy with the combination of Avastin and erlotinib in patients with unresectable hepatocellular carcinoma (HCC). Progression-free survival is defined as the time from initiation of therapy until documented disease progression or death.

Secondary objectives include: response rate, median and overall survival, toxicity and tolerability, and to ascertain whether there is any correlation of response with prior treatment status and underlying HCC risk factor(s).

Detailed description:
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.

Arms: arm 1: Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
Interventions: intervention 1: Bevacizumab (Avastin) intervention 2: Erlotinib
Intervention descriptions: intervention 1: 10 mg/kg IV every 14 days, repeat cycle every 28 days intervention 2: 150 mg orally every day continuous dosing, repeat cycle every 28 days

Protocol documents: