A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
OBJECTIVES:
Primary
- Determine the time to progression in patients with stage III or IV squamous cell
carcinoma of the head and neck treated with bevacizumab in combination with docetaxel
and radiotherapy.
Secondary
- Compare the objective response rate, locoregional control rate, duration of response,
patterns of failure, and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients undergo radiotherapy once daily, 5 days a week, for 8 weeks and receive
docetaxel IV over 1 hour once a week for 8 weeks. Patients also receive bevacizumab IV over
30-90 minutes once every 2 weeks for up to 1 year.
Approximately 8-10 weeks after the completion of chemoradiotherapy, patients may undergo
neck dissection. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after
surgery and continue for 9 months in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma of the head and
neck
- Stage III or IV disease
- No evidence of distant metastases
- No salivary gland or paranasal sinus squamous cell carcinoma
- No disease with close proximity to a major vessel
- Measurable disease
- No known CNS or brain metastases
- Patients with intracranial extension without cerebral involvement may be
eligible
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin normal
- AST and ALT ≤ 2 times upper limit of normal
- PT normal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
- Urine protein: creatinine ratio < 1.0
- No bleeding diathesis or coagulopathy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to study drugs
- No pre-existing peripheral neuropathy ≥ grade 2
- No ongoing or active infection
- No serious non-healing wound, ulcer, or bone fracture
- No New York Heart Association class II-IV congestive heart failure
- No significant arrhythmias requiring medication
- No myocardial infarction within the past 6 months
- No stroke within the past 6 months
- No symptomatic coronary artery disease
- No second- or third-degree heart block or bundle branch block
- No unstable angina pectoris
- No hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
- No other clinically significant heart disease
- No significant traumatic injury within the past 4 weeks
- No psychiatric illness or social situation that would preclude study compliance
- No HIV positivity
- No other malignancy within the past 5 years except squamous cell or basal cell skin
cancer or carcinoma in situ of the cervix
- No other uncontrolled illness
- No poorly compliant patients
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No prior investigational anticancer agents
- More than 4 weeks since prior major surgery
- More than 1 week since prior minor surgery, fine-needle aspiration, or core needle
biopsy
- No concurrent major surgery except planned neck dissection
- No concurrent routine colony-stimulating factor therapy
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression
Outcome Description:
The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained. The probability of disease progression free survival will be estimated by Kaplan-Meier method (39) and 3-year disease progression free survival rate will be then obtained and compared with those in the literature.
Outcome Time Frame:
3 yrs after treatment
Safety Issue:
No
Principal Investigator
Panayiotis Savvides, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CASE6304
NCT ID:
NCT00281840
Start Date:
September 2005
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
| UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
| UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
| UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
