Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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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 |
- 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.
- 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 |
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| 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 | |
| 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:
|
Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Docetaxel Bevacizumab |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013