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ACTIVE NOT RECRUITING
NCT00588770
PHASE3

Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies chemotherapy to see how well it works with or without bevacizumab in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also make tumor cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating patients with head and neck squamous cell carcinoma.

Official title: A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

403

Start Date

2008-08-08

Completion Date

2027-02-20

Last Updated

2026-10-22

Healthy Volunteers

No

Conditions

Neck Squamous Cell Carcinoma of Unknown PrimaryRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Laryngeal Verrucous CarcinomaRecurrent Lip and Oral Cavity Squamous Cell CarcinomaRecurrent Neck Squamous Cell Carcinoma of Unknown PrimaryRecurrent Oral Cavity Verrucous CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Salivary Gland CarcinomaRecurrent Sinonasal Squamous Cell CarcinomaSalivary Gland Squamous Cell CarcinomaStage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IV Major Salivary Gland Cancer AJCC v7Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVA Laryngeal Verrucous Carcinoma AJCC v7Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Major Salivary Gland Cancer AJCC v7Stage IVA Oral Cavity Cancer AJCC v6 and v7Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVB Laryngeal Verrucous Carcinoma AJCC v7Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVB Major Salivary Gland Cancer AJCC v7Stage IVB Oral Cavity Cancer AJCC v6 and v7Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVB Sinonasal Squamous Cell Carcinoma AJCC v7Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVC Laryngeal Verrucous Carcinoma AJCC v7Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVC Major Salivary Gland Cancer AJCC v7Stage IVC Oral Cavity Cancer AJCC v6 and v7Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7Tongue Carcinoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Docetaxel

Given IV

DRUG

Fluorouracil

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Locations (779)

Providence Hospital

Mobile, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

John L McClellan Memorial Veterans Hospital

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

Epic Care-Dublin

Dublin, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Kaiser Permanente South Bay

Harbor City, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Memorial Medical Center

Modesto, California, United States

El Camino Hospital

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Wilma Chan Highland Hospital

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Tom K Lee Inc

Oakland, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Kaiser Permanente-Rio San Diego

San Diego, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

San Diego VA Medical Center

San Diego, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Saint Helena Hospital

St. Helena, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Kaiser Permanente-Franklin

Denver, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Western States Cancer Research NCORP

Denver, Colorado, United States

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Mountain Blue Cancer Care Center

Golden, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Rocky Mountain Cancer Centers-Greenwood Village

Greenwood Village, Colorado, United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

CommonSpirit Saint Anthony Hospital Cancer Center

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Rocky Mountain Cancer Centers-Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers - Pueblo

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

University of Connecticut

Farmington, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Bayhealth Hospital Kent Campus

Dover, Delaware, United States

Beebe Medical Center

Lewes, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

And 679 more locations on ClinicalTrials.gov