Head and Neck Cancer Clinical Trial
Official title:
Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer
Primary Objective:
- To determine the efficacy of the combination of imatinib mesylate and docetaxel in
recurrent or metastatic head and neck squamous cell cancer by serial measurements of
tumor response (extent, frequency, duration).
Secondary Objectives:
- To assess the safety and tolerability of imatinib mesylate and docetaxel in patients
with recurrent or metastatic head and neck squamous cell cancer.
- To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by
immunohistochemical analysis of microvessel density and phosphorylation of
Platelet-derived growth factor receptors (PDGF-R).
- To explore the effects of imatinib mesylate and docetaxel on surrogate markers in
serum.
- To assess the rate of survival.
Imatinib mesylate is designed to block certain proteins important in the growth of cancer.
Docetaxel is designed to target and destroy cancer cells.
If you are found to be eligible to take part in this study, you will take 4 imatinib
mesylate tablets by mouth once a day with a meal and a large glass of water (about 8-10
ounces.) A treatment cycle on this study is 21 days. You should keep normal eating habits,
however a low-fat breakfast is recommended (for example, a light continental breakfast of
toast and juice). Foods and drinks containing caffeine or grapefruit should be avoided. You
should wait at least 1 hour after taking the last tablet before going to bed. If vomiting
occurs, do not take any extra study medication.
You will be given a patient diary to record when you take your medication. You should bring
the diary to each clinic visit, and the study nurse will review it each time.
Docetaxel will be given through a vein in your arm on the first day of each 21-day treatment
cycle for a total of 6 cycles. The infusion will take 1 hour.
You will need to take steroids (dexamethasone) before receiving docetaxel to try to prevent
fluid accumulation and allergic reactions. You will take dexamethasone by mouth twice a day
on the day before the docetaxel infusion, the day of the infusion, and the day after
infusion. You will receive an extra dose of dexamethasone (either through a needle in a vein
or by mouth) on the day of infusion of the chemotherapy either through a needle in a vein or
by mouth.
Every 3 weeks while on this study, you will have a physical exam, including measurement of
your vital signs and weight, and a performance status evaluation. During the first 4 weeks,
blood (about 3 teaspoons each time) will be drawn once a week for routine tests. After that,
blood (about 3 teaspoons each time) will be drawn once at Week 5, once at Week 7, and then
every 3 weeks after that. In addition, your tumor will be measured by a computed tomography
(CT) or magnetic resonance imaging (MRI) scan every 6 weeks (at Weeks 7, 13, and 19).
If you develop any intolerable symptoms or certain changes in your blood tests, your
treatment may be delayed and/or the dose may be decreased until the symptoms are gone. It
may even be necessary to stop your treatment. You will be informed of any changes in your
dosing schedule or in the doses of your medication after your doctor evaluates you in the
clinic.
You may receive up to 6 cycles of the study treatment. Your continued participation in this
study depends on how the cancer responds to the study drugs. Your doctor may decide to take
you off this study if you experience intolerable side effects or the medical condition gets
worse.
After you have completed all of your treatment, you will have an end-of-study visit. At this
visit you will have a physical exam, including measurement of your vital signs and weight.
You will have a performance status evaluation. You will have blood (about 3-4 teaspoons)
drawn for routine tests. Your tumor will be measured by a CT or MRI scan.
This is an investigational study. Imatinib mesylate is FDA approved and docetaxel are FDA
approved for other types of cancer however their use together in this study is
investigational. Dexamethasone is required to be given with docetaxel. All three drugs are
commercially available. Up to 58 patients will take part in this study. All will be enrolled
at M. D. Anderson.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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