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Randomized Phase II Study of Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Phase 2
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of Head and Neck

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Trial Information

Randomized Phase II Study of Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

- Participants will be "randomized" into one of the following study groups: Docetaxel or
Docetaxel with Zactima. Randomization means that participants will be put into a group
by chance.

- The Docetaxel group will receive docetaxel on the first day of every treatment cycle,
which lasts for 3 weeks. Even though treatment will occur once every three weeks,
participants will return to the clinic on a weekly basis for the first two cycles.
After the first two cycles, they will only have to return to the clinic at the start of
each cycle.

- The combination Docetaxel and Zactima group will also receive docetaxel once every
three weeks. In addition to the docetaxel, they will also take a Zactima pill orally
every morning. They will also have to return to the clinic on a weekly basis just as
those in the docetaxel only group.

- The following tests and procedures will be performed during each cycle of treatment,
regardless of which group the participant is randomized into. These are considered
standard of care for treating patients with chemotherapy for recurrent head and neck
cancer: physical exams; blood tests; urine test; nasopharyngoscopy; repeat imaging of
the tumor (x-ray, CT, MRI or PET); photographs of the tumor. In addition to the tests
mentioned above, the Zactima group will have EKGs performed 3 times on the first day of
treatment, once at week 2, then at the beginning of cycles 2 and 3, and then every 6

- Participants will continue on the study as long as they are receiving benefit and are
not experiencing any unmanageable side effects.

Inclusion Criteria:

- Histologically/cytologically documented SCCHN, excluding nasopharyngeal carcinoma.
Squamous cell carcinomas of unknown primary are allowed. Primary salivary gland
tumors and tumor of the nasal cavity and paranasal sinuses are not included.

- 18 years of age or older.

- Evaluable or uni-dimensionally measurable local-regional and/or metastatic disease
that is not amendable to primary surgical resection or radiotherapy.

- Life expectancy of at least 3 months.

- ECOG performance status of 0-2.

- Negative pregnancy test for women of childbearing potential.

- Adequate bone marrow function.

Exclusion Criteria:

- Evidence of sever or uncontrolled systemic disease or any concurrent condition which
in the investigator's opinion makes it undesirable for the patient to participate in
the trial.

- Clinically significant cardiac event such as myocardial infarction, NYHA
classification of heart disease grade II or higher within 3 months of study entry, or
presence of cardiac disease that, in the opinion of the investigator, increases the
risk of ventricular arrhythmia.

- History of arrhythmia which is symptomatic or requires treatment or asymptomatic
sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is
not excluded.

- Previous history of QTc prolongation as a result from other medication that required
discontinuation of that medication.

- Congenital long QT syndrome, or 1st degree relative with unexplained sudden death
under 40 years of age.

- Presence of left bundle branch block.

- QTc with Bazett's correction that is unmeasurable or > 480 msec on screening ECG.

- Any concomitant medication that may cause QTC prolongation, induce Torsades de
Pointes or induce CYP3A4 function.

- Hypertension not controlled by medical therapy.

- Currently active diarrhea that may affect the ability of the patient to absorb

- Pregnant or breast-feeding women.

- Previous or concurrent malignancies of other histologies within the last 5 years,
with the exception of cervical carcinoma in-situ and adequately treated basal cell or
squamous cell carcinoma of the skin.

- Receipt of any investigational agents within 30 days prior to commencing study

- Prior treatment with docetaxel.

- Last dose of prior chemotherapy discontinued less than 3 weeks before start of study

- Last dose of radiation therapy within the last 4 weeks before the start of study
therapy, except palliative radiotherapy.

- Major surgery within 4 weeks, or incompletely healed surgical incision.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess response rate in both groups of patients.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Robert Haddad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

March 2010

Related Keywords:

  • Squamous Cell Carcinoma of Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Loyola University Medical Center/Cardinal Bernadin Cancer Center Maywood, Illinois  60153