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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
docetaxel
conventional surgery
radiation therapy
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  • Lake/University Ireland Cancer Center
  • Southwest General Health Center
  • UHHS Chagrin Highlands Medical Center
  • UHHS Westlake Medical Center
  • UPMC Cancer Centers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bevacizumab with docetaxel and radiation therapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 24, 2006
Last Updated
May 19, 2015
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00281840
Brief Title
Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab with docetaxel and radiation therapy
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
docetaxel IV over 1 hour once a week for 8 weeks
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
radiotherapy once daily, 5 days a week, for 8 weeks
Primary Outcome Measure Information:
Title
Time to Progression
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.
Time Frame
5 yrs after treatment
Secondary Outcome Measure Information:
Title
Response Rate
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
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panayiotis Savvides, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Lake/University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Southwest General Health Center
City
Middleburgh Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
UHHS Chagrin Highlands Medical Center
City
Orange Villager
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
UHHS Westlake Medical Center
City
Westlaker
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24954745
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.
Results Reference
derived
Links:
URL
http://clinicaltrials.gov/ct2/results?term=case6304
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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