Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary

This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and docetaxel when given together with cisplatin and to see how well they work in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also help cisplatin and docetaxel work better by making tumor cells more sensitive to the drugs. Giving sorafenib tosylate, cisplatin, and docetaxel may be an effective treatment for squamous cell carcinoma of the head and neck.

Conditions

• Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
• 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 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
• Salivary Gland Squamous Cell Carcinoma
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IVA Salivary Gland Cancer
• Stage IVA Squamous Cell Carcinoma of the Larynx
• Stage IVA Oral Cavity Squamous Cell Carcinoma
• Stage IVA Squamous Cell Carcinoma of the Oropharynx
• Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage IVA Verrucous Carcinoma of the Larynx
• Stage IVA Verrucous Carcinoma of the Oral Cavity
• Stage IVB Salivary Gland Cancer
• Stage IVB Squamous Cell Carcinoma of the Larynx
• Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVB Squamous Cell Carcinoma of the Oropharynx
• Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage IVB Verrucous Carcinoma of the Larynx
• Stage IVB Verrucous Carcinoma of the Oral Cavity
• Stage IVC Salivary Gland Cancer
• Stage IVC Squamous Cell Carcinoma of the Larynx
• Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVC Squamous Cell Carcinoma of the Oropharynx
• Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Stage IVC Verrucous Carcinoma of the Larynx
• Stage IVC Verrucous Carcinoma of the Oral Cavity
• Tongue Cancer
• Untreated Metastatic Squamous Neck Cancer With Occult Primary

Interventions

DRUG

sorafenib tosylate

Given daily PO in the a.m.

DRUG

cisplatin

Given IV over 1 hour following Docetaxel administration

DRUG

docetaxel

Given IV 1 hour prior to cisplatin administration

OTHER

Correlative Studies

Correlative studies will be performed at the following time points. A total of three biopsies (blood and tumor samples) will be obtained in consenting patients.Pre-treatment biopsy to establish diagnosis and baseline data, Research biopsy obtained at the end of a two week period of sorafenib monotherapy just prior to administration of cycle1 with cisplatin and docetaxel, Research biopsy obtained at the end of two chemotherapy cycles.

Sponsors & Collaborators

• National Comprehensive Cancer Network

  collaborator NETWORK

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Matthew Old, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-14

Primary Completion

2017-04-20

Completion

2017-04-20

FDA Drug

Yes

Countries

• United States

Study Locations