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Clinical Trial Summary

This phase II trial is studying how well giving cetuximab together with bevacizumab works in treating patients with recurrent or metastatic head and neck cancer. Monoclonal antibodies, such as cetuximab and 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. Cetuximab and bevacizumab may also stop the growth of head and neck cancer by blocking blood flow to the tumor. Giving cetuximab together with bevacizumab may kill more tumor cells.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with cetuximab and bevacizumab.

SECONDARY OBJECTIVES:

I. Determine the progression-free and overall survival of patients treated with this regimen.

II. Determine the levels of soluble epidermal growth factor receptor (EGFR) in blood samples before and after dual EGFR and vascular endothelial growth factor inhibition.

III. Evaluate treatment-related toxicities of this regimen in these patients. IV. Collect and bank blood samples for future correlative studies.

OUTLINE: This is a multicenter study. Patients receive cetuximab intravenously (IV) over 1-2 hours on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected at baseline to determine whether biomarkers on tumor tissue and/or blood can be linked with clinical response and to measure signaling pathways by reverse phase protein microarray. Epidermal growth factor receptor (EGFR) gene copy number is assessed by fluorescent in situ hybridization (FISH) on tumor tissue pretreatment. Blood samples are also collected at baseline and on day 21 of course 1 for analysis by acridinium-linked immunosorbent assay (ALISA) to quantify serum p110 sEGFR protein levels.

After completion of study treatment, patients are followed every 2-3 months for 2 years and then every 6 months for 3 years. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Neoplasms
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Nasopharyngeal Neoplasms
  • Oropharyngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • 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
  • 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
  • Tongue Cancer

NCT number NCT00407810
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date October 2006

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