NCT02035527View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

April 14, 2014

Primary Completion Date

April 20, 2017

Study Completion Date

April 20, 2017

Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySalivary Gland Squamous Cell CarcinomaStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Oral Cavity Squamous Cell CarcinomaStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue CancerUntreated 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.

Trial Locations (1)

43210

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus

All Listed Sponsors
collaborator

National Comprehensive Cancer Network

NETWORK

lead

Ohio State University Comprehensive Cancer Center

OTHER

NCT02035527 - Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | Biotech Hunter | Biotech Hunter