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Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer, Squamous Cell Cancer

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Trial Information

Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

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

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

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

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.

Inclusion Criteria:

1. A written, voluntary informed consent form must be completed prior to beginning any
study procedure.

2. Patients >/= 18 years of age.

3. Histologically documented diagnosis of head and neck squamous cell cancer

4. At least one measurable site of disease and can be assessed by Response Evaluation
Criteria In Solid Tumors (RECIST).

5. Performance status 0-2 (Eastern Cooperative Oncology Group, ECOG)

6. Patients must have adequate hepatic, renal, and bone marrow function, defined as the
following: (1) total bilirubin < 1.5 * Upper Limits of Normal (ULN); (2) aspartate
aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 2.5 *
ULN; (3) creatinine < 1.5 * ULN; (4) ANC > 1.5 * 10^9/L; (5) platelets > 100 *

7. Female patients of childbearing potential must have negative pregnancy test within 7
days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Male and
female patients of reproductive potential must agree to employ an effective barrier
method of birth control (i.e. condoms, diaphragm) throughout the study and for up to
3 months following discontinuation of study drug.

8. Patients who have not been treated for recurrent or metastatic head and neck squamous
cell carcinomas (HNSCC) (i.e. Patients who have been treated with chemotherapy for
induction/adjuvant or concurrent therapy with radiation in the setting of definitive
treatment but have now developed recurrent or metastatic disease are eligible).

Exclusion Criteria:

1. Prior exposure to docetaxel or imatinib mesylate.

2. Patient has received any other investigational agents within 30 days of first day of
study drug dosing.

3. Patients with myocardial infarction within the past 6 months or New York Heart
Association class 3 or 4 congestive heart failure.

4. Female patients who are pregnant or breast-feeding.

5. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled
diabetes, chronic renal disease, or active uncontrolled infection (i.e. septic).

6. Patient has unstable brain metastasis. Unstable brain metastasis is defined as
patients on steroid medication to control symptoms or patient with motor neurologic
compromise due to brain metastasis. Patients with treated brain metastasis are
eligible if they are > 6 weeks out from therapy and off all steroid medication.

7. Patient has known chronic liver disease (i.e., chronic active hepatitis or

8. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. HIV
patients are at much greater risk of infection when receiving highly myelosuppressive
agents (docetaxel and imatinib) and for safety reasons are not eligible for this

9. Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C)
prior to study entry, unless the disease is rapidly progressing.

10. Patient previously received radiotherapy to >/= 25 % of the bone marrow

11. Patient had a major surgery within 2 weeks prior to study entry.

12. Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent.

13. Patients must agree not to use herbal remedies or other over-the-counter biologics
(i.e. shark cartilage)

14. History of hypersensitivity to docetaxel or other taxane therapy.

15. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.

16. Patients taking therapeutic levels of warfarin. However, patients receiving 1 mg
daily for catheter related anticoagulation are eligible for the study.

17. Prior pericardial effusion requiring intervention such as pericardiocentesis or
pericardial window within 2 months of study entry.

18. Patient is < 5 years free of another primary malignancy except: if the other primary
malignancy is not currently clinically significant nor requiring active intervention,
or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in
situ. Existence of any other malignant disease is not allowed.

19. Patients with a history of Regional Ileitis, Colitis, or Crohn's disease, or any
other relevant medical history related to the integrity of the bowel wall as there
may be an increased risk of bowel perforation with the combination of Docetaxel and

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participant Response Rate

Outcome Description:

Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.

Outcome Time Frame:

At 6 weeks reconfirmed 6 weeks later

Safety Issue:


Principal Investigator

Anne S. Tsao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

March 2010

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Cancer
  • Head and Neck Cancer
  • Squamous Cell Cancer
  • Imatinib Mesylate
  • Gleevec
  • Imatinib
  • STI571
  • Docetaxel
  • Taxotere
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms



U.T.M.D. Anderson Cancer CenterHouston, Texas  77030