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Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck

Head and Neck Cancer Clinical Trial

Official title:
A Phase II Study of Capecitabine and Lapatinib in Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine together with lapatinib ditosylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine and lapatinib ditosylate together works in treating patients with squamous cell cancer of the head and neck.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. Overall survival (OS) will be the primary endpoint.

SECONDARY OBJECTIVES:

I. Progression free survival (PFS). II. Time to disease progression and sites of progression. III. Response rate. IV. Toxicity of the combination in this population. V. Quality of life.

OUTLINE:

Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 5 years. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Neoplasms, Unknown Primary
  • Oropharyngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • 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 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
  • Salivary Gland Neoplasms
  • Salivary Gland Squamous Cell Carcinoma
  • 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 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
Clinical Trial Details
NCT number NCT01044433
Study type Interventional
Source Abramson Cancer Center of the University of Pennsylvania
Contact
Status Completed
Phase Phase 2
Start date October 2009
Completion date March 3, 2017
View Details
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