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Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00281840
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: bevacizumab
Drug: docetaxel
Procedure: conventional surgery
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Docetaxel Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression measured every 2 months [ Designated as safety issue: No ]
  • Disease response measured every 2 months [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2005
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281840

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Geauga Regional Hospital
Chardonr, Ohio, United States, 44024
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Southwest General Health Center
Middleburgh Heights, Ohio, United States, 44130
UHHS Chagrin Highlands Medical Center
Orange Villager, Ohio, United States, 44122
UHHS Westlake Medical Center
Westlaker, Ohio, United States, 44145
University Suburban Health Center
South Euclid, Ohio, United States, 44121
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Panos Savvides, MD Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000450900, CASE-6304, CASE-030550
Study First Received: January 24, 2006
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00281840  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Docetaxel
Epidermoid carcinoma
Nasopharyngeal carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Bevacizumab
Carcinoma, Squamous Cell
Dental Caries
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009