Clinical trial NCT00281840: Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Time to Progression
timeFrame: 5 yrs after treatment
Secondary outcomes:
measure: Response Rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Mentor
country: United States
facility: Lake/University Ireland Cancer Center
state: Ohio
city: Middleburgh Heights
country: United States
facility: Southwest General Health Center
state: Ohio
city: Orange Villager
country: United States
facility: UHHS Chagrin Highlands Medical Center
state: Ohio
city: Westlaker
country: United States
facility: UHHS Westlake Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Panayiotis Savvides, MD
role: STUDY_CHAIR
References:
citation: Yao M, Galanopoulos N, Lavertu P, Fu P, Gibson M, Argiris A, Rezaee R, Zender C, Wasman J, Machtay M, Savvides P. Phase II study of bevacizumab in combination with docetaxel and radiation in locally advanced squamous cell carcinoma of the head and neck. Head Neck. 2015 Nov;37(11):1665-71. doi: 10.1002/hed.23813. Epub 2014 Oct 29.