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Clinical Trial Summary

This phase II trial is studying how well cediranib maleate works in treating patients with recurrent or newly diagnosed metastatic head and neck cancer. Cediranib maleate may stop the growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the objective clinical response in patients with recurrent or newly diagnosed metastatic squamous cell carcinoma of the head and neck treated with AZD2171 (cediranib maleate).

SECONDARY OBJECTIVES:

I. Determine the safety profile of this drug in these patients. II. Assess the early and late physiological and biological effects of this drug on tumor interstitial fluid pressure, pO2, and tumor microvasculature.

III. Assess the value of potential noninvasive biomarkers of response, including plasma levels of molecules involved in angiogenesis, circulating endothelial cells and progenitor cells, and functional imaging changes before and after treatment.

IV. Assess the gene expression patterns before and after treatment as predictors of clinical and biological response.

OUTLINE: This is a multicenter study.

Patients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo dynamic contrast-enhanced CT imaging and blood collection periodically during study for research studies assessing plasma levels of angiogenic/antiangiogenic molecules, circulating endothelial cells (by flow cytometry), progenitor cells, and protein analysis of potential biomarkers. ;


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
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Verrucous Carcinoma
  • Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
  • Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary
  • Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
  • Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
  • Recurrent Oral Cavity Verrucous Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Recurrent Salivary Gland Carcinoma
  • Salivary Gland Neoplasms
  • Salivary Gland Squamous Cell Carcinoma
  • Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
  • Stage IV Hypopharyngeal Squamous Cell Carcinoma
  • Stage IV Laryngeal Squamous Cell Carcinoma
  • Stage IV Laryngeal Verrucous Carcinoma
  • Stage IV Lip and Oral Cavity Squamous Cell Carcinoma
  • Stage IV Major Salivary Gland Carcinoma
  • Stage IV Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
  • Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma
  • Stage IV Oral Cavity Verrucous Carcinoma
  • Stage IV Oropharyngeal Squamous Cell Carcinoma
  • Tongue Carcinoma
  • Untreated Metastatic Squamous Cell Carcinoma to Neck With Occult Primary

NCT number NCT00458978
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date February 2007
Completion date July 2014

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