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Head and Neck CancerPhase 2NCT00281840

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

A Phase 2 study testing bevacizumab, docetaxel and conventional surgery in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
bevacizumab, docetaxel and conventional surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
6 sitesUnited States
Study dates
Sep 2005to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

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

    Cleveland, Ohio, 44106-5065

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Southwest General Health Center

    Middleburg Heights, Ohio, 44130

  • UHHS Chagrin Highlands Medical Center

    Orange Villager, Ohio, 44122

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • UHHS Westlake Medical Center

    Westlaker, Ohio, 44145

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
bevacizumab, docetaxel, conventional surgery, radiation therapy
Keywords
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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

    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.

  • docetaxelDrug

    docetaxel IV over 1 hour once a week for 8 weeks

  • conventional surgeryProcedure or surgery

    8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection

  • radiation therapyRadiation

    radiotherapy once daily, 5 days a week, for 8 weeks

Study groups in NCT00281840
Study groupRoleWhat they receive
bevacizumab with docetaxel and radiation therapyExperimentalNot described
Receives: Biological: bevacizumab; Drug: docetaxel; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Progression

    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.

    Measured: 5 yrs after treatment

Secondary outcomes (1)

  1. Response Rate

    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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionApr 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281840
Sponsor's protocol ID
CASE6304
Other IDs
P30CA043703, CASE6304, 03-05-50
Status last verified
May 2015
First submitted
24 Jan 2006
Last updated
9 Jun 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24954745

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, docetaxel and conventional surgery in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Progression (time frame: 5 yrs after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.

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