Erlotinib Plus Bevacizumab in Hepatocellular Carcinoma (HCC) as Second-line Therapy

Liver Cancer Clinical Trial

Official title: 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)

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn if the combination of AvastinTM (bevacizumab) and Tarceva (erlotinib hydrochloride) can help to control advanced liver cancer. The safety of this drug combination will also be studied.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

• NCT number: NCT01180959
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: April 14, 2011
• Completion date: May 19, 2021