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

NCT00281840 | Completed Phase 2 Results DMC

• 3 other identifiers: CASE6304P30CA04370303-05-50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  5 yrs after treatment

Secondary Outcomes (1)

• Response Rate

  5 years

Study Arms (1)

bevacizumab with docetaxel and radiation therapy

EXPERIMENTAL

Biological: bevacizumab; Drug: docetaxel; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

bevacizumab BIOLOGICAL

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.

bevacizumab with docetaxel and radiation therapy

docetaxel DRUG

docetaxel IV over 1 hour once a week for 8 weeks

bevacizumab with docetaxel and radiation therapy

conventional surgery PROCEDURE

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

bevacizumab with docetaxel and radiation therapy

radiation therapy RADIATION

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

bevacizumab with docetaxel and radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

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

Cleveland, Ohio, 44106-5065, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Southwest General Health Center

Middleburg Heights, Ohio, 44130, United States

Location

UHHS Chagrin Highlands Medical Center

Orange Villager, Ohio, 44122, United States

Location

UHHS Westlake Medical Center

Westlaker, Ohio, 44145, United States

Location

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• 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 DERIVED

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Bevacizumab; Docetaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Results Point of Contact

• Title: Panayiotis Savvides, MD
• Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Panayiotis.Savvides@uhhospitals.org

216-844-5946

Study Officials

• Panayiotis Savvides, MD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: September 1, 2005
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 9, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-05

Locations

US (6)