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

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.

Conditions

• Neck Squamous Cell Carcinoma of Unknown Primary
• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Verrucous Carcinoma
• Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
• Recurrent Neck Squamous Cell Carcinoma of Unknown Primary
• Recurrent Oral Cavity Verrucous Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma
• Recurrent Salivary Gland Carcinoma
• Recurrent Sinonasal Squamous Cell Carcinoma
• Salivary Gland Squamous Cell Carcinoma
• Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IV Major Salivary Gland Cancer AJCC v7
• Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Laryngeal Verrucous Carcinoma AJCC v7
• Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage IVA Major Salivary Gland Cancer AJCC v7
• Stage IVA Oral Cavity Cancer AJCC v6 and v7
• Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7
• Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IVB Laryngeal Verrucous Carcinoma AJCC v7
• Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage IVB Major Salivary Gland Cancer AJCC v7
• Stage IVB Oral Cavity Cancer AJCC v6 and v7
• Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVB Sinonasal Squamous Cell Carcinoma AJCC v7
• Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IVC Laryngeal Verrucous Carcinoma AJCC v7
• Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage IVC Major Salivary Gland Cancer AJCC v7
• Stage IVC Oral Cavity Cancer AJCC v6 and v7
• Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7
• Tongue 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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Athanassios (Ethan) Argiris · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-08-08

Primary Completion

2018-06-05

Completion

2027-02-20

Countries

• United States
• Puerto Rico
• South Africa

Study Locations