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A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression

Outcome Description:

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.

Outcome Time Frame:

3 yrs after treatment

Safety Issue:

No

Principal Investigator

Panayiotis Savvides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

CASE6304

NCT ID:

NCT00281840

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Lake/University Ireland Cancer CenterMentor, Ohio  44060
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Southwest General Health CenterMiddleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122
UHHS Westlake Medical CenterWestlaker, Ohio  44145