Study on Chemotherapy with Cisplatin/Carboplatin and Docetaxel, with or without Erlotinib, for Treating Head and Neck Cancers That Can Be Surgically Removed

Program Overview

The purpose of this study is to find out if adding erlotinib to a standard chemotherapy treatment (docetaxel with either cisplatin or carboplatin) can better control head and neck squamous cell carcinoma (HNSCC) that can be surgically removed. The study will also look at the safety of this drug combination. Participants will be randomly assigned to receive either erlotinib or a placebo, which looks like the study drug but has no active ingredients. Up to 100 patients will participate, all at MD Anderson.

Description

Study Groups:

If you qualify for this study, you will be randomly placed into one of two groups:

• Group A: You will receive standard chemotherapy with erlotinib.
• Group B: You will receive standard chemotherapy with a placebo.

Initially, you will have an equal chance of being in either group. As the study progresses, you may have a higher chance of being placed in the group that shows better results.

Neither you nor your doctor will know if you are receiving erlotinib or the placebo, but this information can be accessed if necessary for your safety.

Study Drug Administration:

You will receive docetaxel and either cisplatin or carboplatin through an IV on Day 1 of each 3-week cycle, for up to 3 cycles. You will also take erlotinib or placebo tablets daily until the day before your surgery. Take the tablets with water on an empty stomach, at the same time each day. If you vomit and see the tablet, you may take another one.

You will be given standard medications to help reduce side effects. You can ask the study staff for more information about these medications.

Study Visits:

On Day 1 of each cycle, you will receive the study drugs.

Before Cycles 2 and 3:

• You will have a physical exam.
• You will be asked about your smoking and tobacco use.
• Blood will be drawn for routine tests.

After the last dose of chemotherapy:

• You will have a physical exam.
• You will be asked about your smoking and tobacco use.
• Blood will be drawn for routine tests.
• You will have an MRI or CT scan of the head and neck.
• You will complete a questionnaire about your daily life.
• Blood will be drawn for additional testing.

If you can become pregnant, you may have a pregnancy test if your doctor thinks it is needed.

Surgery:

After stopping the study drug/placebo, you will have your scheduled surgery. Tumor tissue will be collected during surgery to check the status and spread of the disease.

Length of Study:

You may receive chemotherapy for up to 3 cycles and take the study drug/placebo until the day before surgery. You will stop taking the study drug if the disease worsens, side effects are intolerable, or you cannot follow study directions.

End of Treatment Visit:

About 8 weeks after surgery, you will have a physical exam, blood tests, and complete a questionnaire. If needed, you will have a pregnancy test.

Long Term Follow Up:

You will be contacted at least once a year to check on your health. Keep your contact information updated with the study staff.

Eligibility Criteria