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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Case Comprehensive Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00281840
First received: January 24, 2006
Last updated: July 19, 2012
Last verified: July 2012
  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
Biological: bevacizumab
Drug: docetaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 3 yrs after treatment ] [ Designated as safety issue: No ]
    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. The probability of disease progression free survival will be estimated by Kaplan-Meier method (39) and 3-year disease progression free survival rate will be then obtained and compared with those in the literature.


Secondary Outcome Measures:
  • Response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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).


Enrollment: 30
Study Start Date: September 2005
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bevacizumab with docetaxel and radiation therapy 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281840

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
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
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Panayiotis Savvides, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00281840     History of Changes
Other Study ID Numbers: CASE6304, P30CA043703, CASE6304, 03-05-50
Study First Received: January 24, 2006
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Bevacizumab
Docetaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014