NCT00281840 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2015-06-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Time to Progression

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outcome · POSTED

Response Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Biological: bevacizumab
Drug: docetaxel
Procedure: conventional surgery
Radiation: radiation therapy
label
bevacizumab with docetaxel and radiation therapy
type
EXPERIMENTAL

interventions

arm Group Labels
bevacizumab with docetaxel and radiation therapy
description
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.
name
bevacizumab
type
BIOLOGICAL
arm Group Labels
bevacizumab with docetaxel and radiation therapy
description
docetaxel IV over 1 hour once a week for 8 weeks
name
docetaxel
type
DRUG
arm Group Labels
bevacizumab with docetaxel and radiation therapy
description
8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection
name
conventional surgery
type
PROCEDURE
arm Group Labels
bevacizumab with docetaxel and radiation therapy
description
radiotherapy once daily, 5 days a week, for 8 weeks
name
radiation therapy
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 30
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Time to Progression
time Frame
5 yrs after treatment

secondary Outcomes

description
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). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
measure
Response Rate
time Frame
5 years

Full study description

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.

Source references

references

citation
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.
pmid
24954745
type
DERIVED