Head and Neck Cancer Clinical Trial
Official title:
A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
Verified date | May 2015 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such
as docetaxel, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to
kill tumor cells. Giving bevacizumab together with docetaxel and radiation therapy may kill
more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel
and radiation therapy works in treating patients with stage III or stage IV head and neck
cancer.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | Lake/University Ireland Cancer Center | Mentor | Ohio |
United States | Southwest General Health Center | Middleburgh Heights | Ohio |
United States | UHHS Chagrin Highlands Medical Center | Orange Villager | Ohio |
United States | UPMC Cancer Centers | Pittsburgh | Pennsylvania |
United States | UHHS Westlake Medical Center | Westlaker | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Progression | 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. | 5 yrs after treatment | No |
Secondary | Response Rate | The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD | 5 years | No |
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