Clinical trial NCT00942734
Conditions: Head And Neck Cancer
Keywords: Head and Neck Squamous Cell Carcinoma RAD001 Erlotinib Everolimus OSI-774 Tarceva
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-07-01; Completion date: 2014-11-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if RAD001 in combination with Tarceva (erlotinib hydrochloride) can help to control head and neck squamous cell cancer (HNSCC). The safety of this drug combination will also be studied.

Detailed description:
The Study Drugs:

RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, and this may cause the tumor cells to die.

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.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take 1 RAD001 tablet and 1 erlotinib hydrochloride tablet every day of each 28 day study "cycle".

Both drugs should be taken at the same time, by mouth, with a cup (8 ounces) of water. You should take the drugs at least 1 hour before or 2 hours after eating. You should take the study drugs at around the same time each day. Your eating habits around the time you take the drugs should stay the same while you are on study. lf you vomit, you should not take another tablet until your next scheduled dose.

Tell your doctor if you have any side effects, as your dose(s) of study drug(s) may be lowered or stopped for a few days. You may be given drugs to help reduce the risk of side effects.

Study Visits:

On Day 1 (+/- 3 days) of each cycle, the following tests and procedures will be performed:

* You will have a complete physical exam, including measurement of your weight and vital signs.
* You will be asked about any drugs you may be taking and any side effects you may be having.
* Your performance status will be recorded.
* Blood (about 3 teaspoons) will be drawn for routine tests. If your doctor thinks it is needed, you may have to have these blood tests more often.

On Day 1 (+/- 3 days) of every evenly numbered cycle (Cycles 2, 4, 6, and so on), you will have a CT scan or MRI scan to check the status of the disease.

Length of Study:

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

End-of-Study Visit:

When you go off study for any reason, you will have an end-of-study visit. The following tests and procedures will be performed:

* Your medical history will be recorded.
* You will have a complete physical exam, including measurement of your weight and vital signs.
* You will be asked about any drugs you may be taking and any side effects you may be having.
* Your performance status will be recorded.
* Blood (about 3 teaspoons) will be drawn for routine tests.
* You will have a CT scan or MRI scan to check the status of the disease.

Follow-Up:

You will be called within 30 days after the end-of-study visit and asked how you are doing and about any possible side effects that you may have had. The call should take about 5 minutes.

This is an investigational study. RAD001 is FDA approved and commercially available for the treatment of certain types of breast cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of advanced non-small cell lung carcinoma (NSCLC) and advanced pancreatic cancer. The use of this drug combination for the treatment of HNSCC is investigational.

Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: RAD001 1 tablet (5 mg) by mouth every day of each 28 day study cycle. Erlotinib one tablet (150 mg) by mouth every day of each 28 day study cycle.
Interventions: intervention 1: Erlotinib intervention 2: RAD001
Intervention descriptions: intervention 1: One tablet (150 mg) by mouth every day of each 28 day study cycle. intervention 2: 1 tablet (5 mg) by mouth every day of each 28 day study cycle.

Protocol documents: