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

NCT ID: NCT00281840

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bevacizumab with docetaxel and radiation therapy

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: BIOLOGICAL

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.

docetaxel

Intervention Type: DRUG

docetaxel IV over 1 hour once a week for 8 weeks

conventional surgery

Intervention Type: PROCEDURE

8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection

radiation therapy

Intervention Type: RADIATION

radiotherapy once daily, 5 days a week, for 8 weeks

Interventions

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.

Intervention Type: BIOLOGICAL

docetaxel

docetaxel IV over 1 hour once a week for 8 weeks

Intervention Type: DRUG

conventional surgery

8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection

Intervention Type: PROCEDURE

radiation therapy

radiotherapy once daily, 5 days a week, for 8 weeks

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Panayiotis Savvides, MD

Role: STUDY_CHAIR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

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

Middleburg Heights, Ohio, United States

UHHS Chagrin Highlands Medical Center

Orange Villager, Ohio, United States

UHHS Westlake Medical Center

Westlaker, Ohio, United States

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24954745 (View on PubMed)

Related Links

http://clinicaltrials.gov/ct2/results?term=case6304

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

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE6304

Identifier Type: OTHER

Identifier Source: secondary_id

03-05-50

Identifier Type: OTHER

Identifier Source: secondary_id

CASE6304

Identifier Type: -

Identifier Source: org_study_id