Phase II Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
It is believed to be weakly effective at killing blood vessels in cancer cells as well.
Cisplatin has an atom at its center that contains platinum. The platinum is supposed to
poison the cancer cells, which may cause them to die.
5-Fluorouracil is designed to destroy cancer cells by preventing them from dividing and
multiplying .
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive 5-fluorouracil
through a needle in your vein, non-stop, on Days 1-4 of each 21-day study "cycle". On Day 1
only, you will receive docetaxel over 1 hour and cisplatin over 30-180 minutes. You will
receive 2-3 cycles of therapy.
If you are having side effects, the study doctor may schedule you to receive the study drugs
on a longer cycle.
Study Visits:
During Weeks 1-3 of Cycles 1 and 2, you will have study visits during the week that you
receive chemotherapy treatment. At these visits, the following tests and procedures will be
performed:
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Your medical history will be recorded, including measurement of your height and weight.
- Your doctor will ask about any side effects you may be experiencing.
- You will have a physical exam, including measurement of your vital signs.
- Your skin and inside of your mouth will be examined by your doctor.
- You will be asked how well you are able to perform the normal activities of daily
living (performance status evaluation).
- You will have a hearing test.
Once Cycle 2 is completed, you will have the following tests and procedures performed to
learn if the disease has responded to the therapy:
- Blood (about 2 teaspoons) will be collected for routine tests.
- You will have a physical exam, including measurement of your vital signs.
- Your medical history will be recorded, including measurement of your height and weight.
- You will have a nasal endoscopy.
- You will have a CT or MRI scan to check the status of the disease.
- Your doctor will ask about any side effects you may be experiencing.
- Your performance status will be checked.
- The nerve function in your head and neck will be checked by hand.
- If your doctor thinks it is necessary, you will have a chest x-ray.
- If your doctor thinks it is necessary, you will have bone scans.
- If your liver tests were abnormal and your doctor thinks it it is necessary, you will
have a CT scan of your abdomen.
- If your doctor thinks it is necessary, you will have a positron emission tomography
(PET) or PET-CT.
- You will have an eye exam.
Chemotherapy or Radiotherapy:
Based on the results of the tests and procedures performed to check to see if the disease
has responded, your doctor will decide your next treatment.
If you respond partly or completely, you will receive a 3rd cycle of chemotherapy. You will
follow the same schedule as you did during the first 2 cycles. Once you complete the 3
cycles of chemotherapy, you will begin chemoradiation. Your doctor will discuss this with
you in more detail and you will receive a separate consent form.
If the disease does not respond partly or completely, you will have surgery followed by
radiotherapy. Before surgery, you will be asked to sign a separate informed consent. Risks
will be discussed with your treating doctor and will depend on the type of surgery. Before
radiotherapy, you will be asked to sign a separate informed consent that will describe
possible risks.
Additional Cycles:
If the disease responds partly or completely, you will receive an additional (third) cycle
of therapy. If you have the additional cycle, you will follow the same schedule as you did
during Cycles 1 and 2. Before you receive the additional cycle, you will have a hearing
test.
Study Visit After Chemoradiation:
If you receive chemoradiation, after your last chemotherapy treatment you will have the
following tests and procedures performed:
- You will have a physical exam, including measurement of your vital signs.
- Your medical history will be recorded, including measurement of your height and weight.
- The nerve function in your head and neck will be checked by hand.
- You will have a nasal endoscopy.
- You will have an MRI.
- Your doctor will ask about any side effects you may be experiencing.
- If your doctor thinks it is necessary, you will also have a CT or positron emission
tomography (PET)-CT scan.
Length of Study:
You will remain on study treatment for 16-20 weeks. You will be taken off study early if the
disease gets worse or intolerable side effects occur.
Follow-up/End-of-Treatment Visits:
If the disease responded completely while you were on study, you will have follow-up visits
every 3 months during Years 1-2, every 4 months during Year 3, and every 6 months during
Years 4-5. If the disease did not respond completely and you are having side effects at the
end-of-study visit, you will have follow-up visits every 4 weeks until the side effects go
away. At each visit, the following tests and procedures will be performed:
- Your complete medical history will be recorded, including measurement of your height
and weight.
- You will have a physical exam, including measurement of your vital signs.
- You will have a nasal endoscopy.
- The nerve function in your head and neck will be checked.
- Your doctor will ask about any side effects you may be experiencing.
- Your performance status will be checked.
- One (1) time each year, blood (about 2 teaspoons) will be drawn for a thyroid function
test.
If the disease responded completely while you were on study, additional tests and procedures
will also be performed at 6 months during Year 1, then yearly during Years 1-3. The
following tests will also be performed:
- You will have an eye exam.
- You will have a hearing test.
- You will have a dental exam.
- You will complete a questionnaire that will ask you to rate your symptoms and how much
they may interfere with your daily activities. This will take about 10 minutes to
complete.
- You will have saliva flow tests.
- You will have a CT or MRI scan to check the status of the disease.
- If your doctor thinks it is necessary, you will have a chest x-ray.
- If your doctor thinks it is necessary, you will have bone scans.
- If your liver tests were abnormal and your doctor thinks it it is necessary, you will
have a CT scan of your abdomen.
- If your doctor thinks it is necessary, you will have a positron emission tomography
(PET) or PET-CT.
This is an investigational study. Docetaxel is FDA approved for the treatment of certain
types of breast cancer, gastric cancer, prostate cancer, and advanced squamous cell
carcinoma of the head and neck.
Cisplatin is FDA approved to be used together with other drugs to treat advanced ovarian
cancer, testicular cancer, locally advanced squamous cell carcinoma of the head and neck,
late-stage cervical cancer, and non-small cell lung cancer.
5-fluorouracil is FDA approved to be used with other drugs to treat metastatic colorectal
cancer, locally advanced squamous cell carcinoma of the head and neck, and gastric
adenocarcinoma.
The use of these drugs to treat cancer of the nasal cavity or paranasal sinuses is
investigational.
Up to 45 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
Number of Patients with Complete + Partial Response
Clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF).
Response assessment after two 3 week cycles, then every 6 months for minimally 2 years
No
Ehab Y. Hanna, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2007-0433
NCT00707473
June 2008
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |