Status:
COMPLETED
Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this research study, the researchers are comparing the combination of docetaxel and Zactima with docetaxel alone to see if the combination of the two drugs will be more effective than docetaxel alo...
Detailed Description
* 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 Docetax...
Eligibility Criteria
Inclusion
- 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
- 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 Zactima.
- 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 treatment.
- Prior treatment with docetaxel.
- Last dose of prior chemotherapy discontinued less than 3 weeks before start of study therapy.
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00459043
Start Date
March 1 2007
End Date
February 1 2012
Last Update
July 3 2013
Active Locations (3)
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1
Loyola University Medical Center/Cardinal Bernadin Cancer Center
Maywood, Illinois, United States, 60153
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115