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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281840
• Other study ID #: CASE6304
• Secondary ID: P30CA043703CASE6
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: May 19, 2015
• Start date: September 2005
• Est. completion date: December 2012

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• bevacizumab
Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. 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.

Drug:
• docetaxel
docetaxel IV over 1 hour once a week for 8 weeks

Procedure:
• conventional surgery
8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection

Radiation:
• radiation therapy
radiotherapy once daily, 5 days a week, for 8 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database