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

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Radiation: radiation therapy

Drug: docetaxel

Procedure: conventional surgery

Biological: bevacizumab

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00281840

P30CA043703 (U.S. NIH Grant/Contract)

CASE6304 (Other Identifier)

03-05-50 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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