Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

Conditions

• Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
• Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
• Recurrent Basal Cell Carcinoma of the Lip
• Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Recurrent Lymphoepithelioma of the Nasopharynx
• Recurrent Lymphoepithelioma of the Oropharynx
• Recurrent Metastatic Squamous Neck Cancer With Occult Primary
• Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
• Recurrent Salivary Gland Cancer
• Recurrent Squamous Cell Carcinoma of the Hypopharynx
• Recurrent Squamous Cell Carcinoma of the Larynx
• Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
• Recurrent Squamous Cell Carcinoma of the Nasopharynx
• Recurrent Squamous Cell Carcinoma of the Oropharynx
• Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Recurrent Verrucous Carcinoma of the Larynx
• Recurrent Verrucous Carcinoma of the Oral Cavity
• Stage III Adenoid Cystic Carcinoma of the Oral Cavity
• Stage III Basal Cell Carcinoma of the Lip
• Stage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Stage III Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Stage III Lymphoepithelioma of the Nasopharynx
• Stage III Lymphoepithelioma of the Oropharynx
• Stage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Stage III Mucoepidermoid Carcinoma of the Oral Cavity
• Stage III Salivary Gland Cancer
• Stage III Squamous Cell Carcinoma of the Hypopharynx
• Stage III Squamous Cell Carcinoma of the Larynx
• Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage III Squamous Cell Carcinoma of the Nasopharynx
• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage III Verrucous Carcinoma of the Larynx
• Stage III Verrucous Carcinoma of the Oral Cavity
• Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
• Stage IV Basal Cell Carcinoma of the Lip
• Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
• Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
• Stage IV Lymphoepithelioma of the Nasopharynx
• Stage IV Lymphoepithelioma of the Oropharynx
• Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
• Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
• Stage IV Salivary Gland Cancer
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Larynx
• Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Oropharynx
• Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage IV Verrucous Carcinoma of the Larynx
• Stage IV Verrucous Carcinoma of the Oral Cavity
• Untreated Metastatic Squamous Neck Cancer With Occult Primary

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• hydroxyurea — DRUG
  Given orally
• fluorouracil — DRUG
  Given IV
• bevacizumab — BIOLOGICAL
  Given IV
• radiation therapy — RADIATION
  Undergo radiotherapy
• filgrastim — BIOLOGICAL
  Given subcutaneously
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may be an effective treatment for head and neck cancer. This phase I trial is to see if combining bevacizumab, fluorouracil, and hydroxyurea with radiation therapy works in treating patients who have advanced head and neck cancer

Key Dates

First listed

Jan 27, 2003

Start date

Jul 31, 2001

Status verified

Feb 2013

Primary completion

Mar 31, 2010

Study Design

Enrollment

39 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (hydroxyurea, fluorouracil, bevacizumab, radiation)
  Patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, and bevacizumab IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Patients receive G-CSF subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0 [ Time Frame: 14 weeks ]

Locations (1)

Find similar trials in Chicago, IL

Related Studies

• Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
  Recruiting · Ohio State University Comprehensive Cancer Center · Columbus, Ohio