Status:
COMPLETED
Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 radio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00281840
Start Date
September 1 2005
End Date
December 1 2012
Last Update
June 9 2015
Active Locations (6)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
2
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
3
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
4
UHHS Chagrin Highlands Medical Center
Orange Villager, Ohio, United States, 44122