Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Docetaxel

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