Erlotinib in Combination With Cetuximab

Advanced Cancers Clinical Trial

Official title: A Phase I Dose-Escalation Study of Erlotinib in Combination With Cetuximab in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638.

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab). The safety of this drug combination will also be studied.

Clinical Trial Description

The Study Drugs:

Erlotinib and cetuximab are both designed to block a certain protein, called epidermal growth factor receptor (EGFR), that is thought to cause cancer cells to grow. These drugs may help slow the growth of tumors.

Study Drug Dose Level:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of erlotinib hydrochloride and cetuximab based on when you join the study. Up to 4 dose levels of this study drug combination will be tested. There will be 3-6 participants enrolled at each dose level of the study drug combination.

The first group of participants will receive the lowest dose level of erlotinib hydrochloride (Group 1). If all of Group 1 tolerate that dose level, the next group (Group 2) will receive a higher dose. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen (Groups 2-4). This will continue until the highest tolerable dose of the study drug combination is found. However, if Group 1 did not tolerate the first dose level, the next group will receive a lower dose (called Dose Level -1). If that dose level is still intolerable, the third group will receive an even lower dose (called Dose Level -2).

The dose of cetuximab will be based in which group you in. Groups 1-3 will receive the same dose and Group 4 will receive a higher dose.

After the highest tolerable dose is found, up to an additional 10 participants, called the "expansion group," will receive the study drug combination at that dose.

Study Drug Administration:

Erlotinib hydrochloride will be taken by mouth 1 time every day for 28-days, called a study "cycle." You should take erlotinib hydrochloride on an empty stomach either 1 hour before eating or 2 hours after eating.

Cetuximab will be given by vein 1 time every week. The first time you receive cetuximab, it will be given over 2 hours. Every time you receive cetuximab after that, it will be given over 1 hour.

Study Visits:

You will have a single study visit just before the start each cycle. At these visits, the following tests and procedures will be performed:

• Your performance status will be recorded.

• You will be asked to list any drugs you may be taking, including over-the-counter drugs.

• You will be asked about any symptoms you may have.

• You will have a physical exam, including measurement of your vital signs.

• Blood (about 2 teaspoons) will be collected for routine tests.

• Blood (about 2 teaspoons) will be collected for pharmacodynamic (PD) testing. PD testing is used to look at how the level of study drug in your body may affect the disease.

After the first 2 cycles and then every 2 to 3 cycles, you will have a CT or MRI scan to check the status of the disease.

Length of Study:

You may continue taking the study drugs for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.

Follow-up Visit:

About 30 days after the last dose of study drugs, you will have a follow-up visit. You will be asked to return any unused study drugs. At this visit, the following tests and procedures will be performed:

• Your performance status will be recorded.

• You will be asked to list any drugs you may be taking, including over-the-counter drugs.

• You will be asked about any symptoms you may have.

• You will have a physical exam, including measurement of your vital signs.

• Blood (about 2 teaspoons) and urine will be collected for routine tests.

This is an investigational study. Cetuximab and Erlotinib hydrochloride are both FDA approved and commercially available. Cetuximab is FDA approved for the treatment of colorectal cancer and cancer of the head and neck. Erlotinib hydrochloride is FDA approved for the treatment of lung cancer and pancreatic cancer. The use of these drugs together is investigational and authorized for use in research only.

Up to 48 participants will take part in this study. All will be enrolled at MD Anderson. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancers
• Neoplasms

• NCT number: NCT00895362
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: April 2009