Randomized Phase II Trial Contrasting Weekly Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Treatment on this study consists of 2 parts. The first part of your treatment is called
induction chemotherapy and will last for 6-9 weeks, depending on which group you are in. The
second part of treatment will be radiation therapy (either with or without chemotherapy).
The type of treatment you will receive depends on the site and stage of the disease.
Study Drugs:
Paclitaxel, carboplatin, and 5-fluorouracil are designed to block cancer cells from
dividing, which may cause them to die.
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
It may also damage blood vessels in tumor tissue.
Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer
cells, which may cause them to die.
Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking
proteins inside the cancer cell, called the epidermal growth factor receptor (EGFR).
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 groups. There is an equal chance of being assigned to
either group.
- If you are in Group A, you will receive cetuximab, paclitaxel, and carboplatin.
- In you are in Group B, you will receive cetuximab, docetaxel, cisplatin, and
5-fluorouracil.
Part 1 Study Drug Administration:
Group A:
During induction, you will receive cetuximab, paclitaxel, and carboplatin by vein once a
week for 6 weeks. During Week 1, the cetuximab infusion will last about 2 hours. During
Weeks 2-6, the cetuximab infusion will last about 1 hour. Following the cetuximab infusion,
you will receive paclitaxel over about 1 hour followed by carboplatin over about 1 hour.
Your vital signs will be monitored before, during, and after the cetuximab infusion.
Group B:
During induction, you will receive cetuximab, docetaxel, and cisplatin by vein. You will
also receive 5-fluorouracil as a non-stop infusion over 4 days through an infusion pump.
This pump is portable so that you can have this treatment on an outpatient basis.
On Day 1 of each 21-day cycle:
- You will receive cetuximab over about 1-2 hours.
- You will receive docetaxel over about 1 hour.
- You will receive cisplatin over about 1-3 hours
- You will then begin receiving 5-fluorouracil. This infusion will be non-stop over the
next 4 days.
On Day 2 of each cycle, you will receive saline (salt water) to prevent dehydration.
On Days 5-10 of each cycle, you will take antibiotics, by mouth, to prevent infection. Your
doctor will tell you what type of antibiotic to take.
On Day 8 of each cycle, you will receive cetuximab over about 1 hour.
You will have 3 cycles of induction therapy.
Other drugs may be given before you receive the study drugs to prevent side effects. You
will be closely monitored for side effects during the infusions in the clinic setting before
you will be allowed to leave.
Part 1 Study Visits:
Every week:
- You will have a physical exam, including measurement of your weight.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- You will be asked about any drugs you may be taking.
- You will be asked about any side effects you may be having.
After you have completed your induction therapy, you will have a CT scan, MRI scan, and/or a
PET-CT to check the status of the disease.
Part 2 Study Drug Administration:
Before you begin radiation, you will have a dental exam.
You will begin either radiation with chemotherapy or radiation without chemotherapy. Your
doctor will decide which treatment is best for you.
All participants will begin radiation about 2-4 weeks after induction therapy. You will
receive radiation Monday through Friday for about 7 weeks, or as recommended by the treating
radiologist.
If you are receiving radiation with chemotherapy, you will receive carboplatin or cisplatin
every week while you are receiving radiation. If you receive cisplatin, it will be given by
vein over about 1-3 hours. If you are given carboplatin, it will be given by vein over about
1 hour.
Part 2 Study Visits:
Every week:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- Your skin and the lining of your mouth will be checked for sores.
Follow-Up Phase:
About 6 weeks after you finish all treatments:
- You will have a physical exam.
- You will have a chest x-ray.
- You will be asked about any side effects you may be having.
- You will be asked about any drugs you are taking.
- Your skin and the lining of your mouth will be checked for sores.
If you were in Group B, you will have a CT scan, MRI scan, and/or PET/CT scan at 6 weeks
(+/- 14 days) after you have completed radiation/chemoradiation to check the status of the
disease.
If you were in Group A, you will have a CT scan, MRI scan, and/or PET/CT scan at 9 weeks
(+/- 14 days) after you have completed radiation/chemoradiation to check the status of the
disease.
Six (6), 12, and 24 months after you finish treatment, you will have a videofluoroscopic to
check your swallowing. You will complete a separate consent form for this procedure. You
will also complete the questionnaire about your day-to-day activities.
All participants will have clinic visits every 3 months for 2 years, every 6 months through
years 3 and 4, and yearly through year 5. At these visits:
- You will have a physical exam.
- You will have a chest x-ray.
- You will be asked about any side effects you may be having.
- You will be asked about any drugs you are taking.
- If your doctor thinks it is needed, you will have additional tests/procedures
performed.
After the Year 5 follow up visit, you will be contacted by a member of the study team by
phone or by letter and asked about you how you are doing and if you have received any other
treatment for cancer.
Length of Study:
You will remain on treatment for about 15-16 weeks. If, during that time, the disease gets
worse or you experience intolerable side effects, you will be taken off study.
This is an investigational study. All of the study drugs are FDA approved and commercially
available. The combination of these drugs when given to patients with locally advanced head
and neck squamous cell carcinoma is investigational.
Up to 128 patients will take part in this multicenter study. Up to 100 will be enrolled MD
Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Progression-free survival (PFS)
2 Years
No
Vali Papadimitrakopoulou, MD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0885
NCT01154920
July 2010
Name | Location |
---|---|
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
UT MD Anderson Cancer Center | Houston, Texas 77030 |