A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer
The Study Drugs:
Sorafenib is a drug that is designed to block the function of important proteins in cancer
cells. These proteins, when active, are in part responsible for the abnormal growth and
behavior of cancer cells.
Carboplatin and paclitaxel are designed to work by stopping the division of cancer cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin receiving
sorafenib, carboplatin, and paclitaxel.
On Day 1, paclitaxel will be given through a needle in your vein over 3 hours, followed by
carboplatin by vein over 30 minutes.
On Days 2-19, you will take sorafenib by mouth or by stomach tube. You will take 2 tablets
of sorafenib each morning, and again each evening. Sorafenib should be taken with about 1
cup (8 ounces) of water on an empty stomach (either 1 hour before a meal or 2 hours after a
meal). Sorafenib must be swallowed whole without chewing or prepared using instructions
provided on the patient handout for preparing sorafenib as a liquid. If you miss a dose, you
should skip it and take the next scheduled dose at the scheduled time. Every 21 days is
called a study "cycle".
You may be given medications before receiving the study drugs to decrease the risk of nausea
and allergic reaction.
Study Visits:
On Days 1, 8, and 15 of Cycle 1 you will have the following tests and procedures performed:
- You will have a physical exam.
- Blood (about 1-2 teaspoons) and urine will be collected for routine tests.
- You will have a performance status evaluation.
- Blood (about 1-2 tablespoons) will be drawn to check to see how well your blood clots.
On Day 1 of Cycles 2 and beyond, you will have the following tests and procedures performed:
- You will have a physical exam, including measurement of vital signs (blood pressure,
heart rate, temperature, and breathing rate).
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn to check how well your blood clots.
Every week for the first 6 weeks on study treatment, you will measure and record your blood
pressure. The study staff will explain to you how to measure your blood pressure. The study
doctor or research nurse will review the log at each clinic visit.
On Day 1 of every odd cycle (Cycles 3 and 5), you will have a chest x-ray and CT or MRI
scans to check the status of the disease.
Length of Study:
You may receive up to 6 cycles of treatment with the 3 study drugs. However, you may
continue receiving sorafenib for as long as you are benefitting. You will be taken off study
early if the disease gets worse or intolerable side effects occur.
Study Visits for Sorafenib Treatment Only:
If you continue to receive sorafenib after you have finished with the 6 cycles of treatment
with the 3 study drugs, you will take the sorafenib every day. You will have study visits
every 8 weeks. At these visits, you will have the following tests and procedures performed:
- You will have a physical exam.
- Blood (around 2 teaspoons) and urine will be collected for routine tests.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn to check how well your blood clots.
- You will have a chest x-ray and CT or MRI scan to check the status of the disease every
2 cycles.
End-of-Study Visit:
At the end of study treatment, you will have the following tests and procedures performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
- Blood (around 2 teaspoons) and urine will be collected for routine tests.
- Blood (about 1-2 teaspoons) will be drawn to check how well your blood clots.
- You will have a performance status evaluation.
- You will have a chest x-ray and CT or MRI scan to check the status of the disease.
- You will also have an ECG.
This is an investigational study. Sorafenib is FDA approved for treatment of advanced renal
cell cancer. Its use in this study, for this disease, is investigational. Carboplatin and
paclitaxel are FDA approved and commercially available. Up to 40 patients will take part in
this study. All will be enrolled at M. D. Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Overall Response Rate
3 years
No
George Blumenschein, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2006-0940
NCT00494182
April 2007
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |