Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Docetaxel — DRUG
  Given IV
• Fluorouracil — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies

Study Details

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.

Key Dates

First listed

Jan 9, 2008

Start date

Aug 8, 2008

Status verified

Feb 2026

Primary completion

Jun 5, 2018

Completion

Feb 20, 2027

Study Design

Enrollment

403 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm IA (docetaxel, cisplatin)
  Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm IB (docetaxel, cisplatin, bevacizumab)
  Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.
• Active Comparator: Arm IIA (docetaxel, carboplatin)
  Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm IIB (docetaxel, carboplatin, bevacizumab)
  Patients receive bevacizumab as in Arm IB and docetaxel and carboplatin as in Arm IIA.
• Active Comparator: Arm IIIA (cisplatin, fluorouracil)
  Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm IIIB (cisplatin, fluorouracil, bevacizumab)
  Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.
• Active Comparator: Arm IVA (carboplatin, fluorouracil)
  Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm IVB (carboplatin, fluorouracil, bevacizumab)
  Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry ]

Locations (779)

Find similar trials in Mobile, AL

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