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

PRIMARY OBJECTIVES:

I. To define progression-free survival of patients with recurrent/metastatic squamous cell
carcinoma treated with cisplatin/docetaxel/sorafenib (sorafenib tosylate) (CDS) combination
chemotherapy. (Phase II) II. To determine the optimal doses of cisplatin/docetaxel/sorafenib
to be used in the phase II portion of the trial. (Phase I)

SECONDARY OBJECTIVES:

I. To determine overall survival, response rate, conduct biomarker studies, toxicities.

OUTLINE: This is a phase I, dose-escalation study of sorafenib tosylate and docetaxel
followed by a phase II study.

Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-14 of course 0.
Beginning in course 1, patients receive sorafenib tosylate PO BID on days 1-21, docetaxel
intravenously (IV) over 1 hour on day 1, and cisplatin IV over 1 hour on day 1. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients then receive sorafenib tosylate PO BID in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Inclusion Criteria:

- Patients must have histologic or cytologic proof of recurrent/metastatic squamous cell
carcinoma of the head and neck (SCCHN) of any primary site, including unknown primary
cancers of the head and neck excluding nasopharyngeal carcinoma of histologic types
World Health Organization (WHO) 2 or 3, paranasal sinuses primary or squamous cell
carcinoma that originated in the skin

- Patients must have SCCHN that is either (a) recurrent, judged incurable by surgery or
(chemo)radiation or (b) metastatic

- Patients must not have received prior chemotherapy for recurrent or metastatic disease

- Patients may have received one regimen of induction, concomitant chemoradiotherapy
and/or adjuvant chemotherapy as part of their initial treatment with curative intent,
which must have been completed for a minimum of 4 months prior to study treatment and
patient must have been progression-free for at least 4 months since completion of
treatment with curative intent

- Patients with recurrent disease are allowed a maximum of one prior radiation therapy
regimen, either curative or palliative

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

- Patients must have measurable disease using Response Evaluation Criteria in Solid
Tumors (RECIST) criteria; patients must have measurable disease, defined as at least
one lesion that can be accurately measured in at least one dimension (longest diameter
to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm
with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan,
magnetic resonance imaging (MRI), or calipers by clinical exam

- Absolute neutrophil count (ANC) 1500/mm^3

- Platelet count 100,000/mm^3

- Creatinine within normal limits (WNL), or creatinine clearance >= 60 ml/min, based on
the Cockroft-Gault formula

- Total bilirubin WNL

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than twice the
upper normal limit

- Patients must have controlled blood pressure (150/90) prior to initiation of treatment

- Women must not be pregnant or breast feeding; women of child-bearing potential and men
must agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for the duration of study participation; should a
woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately; men
treated or enrolled on this protocol must also agree to use adequate contraception
prior to the study, for the duration of study participation, and 4 months after
completion of sorafenib administration

- Patients must be human immunodeficiency virus (HIV)-negative

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 3 months prior to entering
the study

- Patients who are receiving any other investigational agents

- Patients with known brain metastases will be excluded from this clinical trial

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sorafenib, docetaxel, cisplatin

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm
Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events
(CTCAE) version (v)4.0] on repeated measurement) despite optimal medical management

- Evidence or history of bleeding diathesis or coagulopathy

- Subject with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 grade 2 or
higher within 4 weeks before randomization; any other hemorrhage/bleeding event of
NCI-CTCAE v4.0 grade 3 or higher within 4 weeks before randomization

- Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular
accident (including transient ischemic attacks) within 6 months of informed consent

- Subjects who have used strong cytochrome P450 family 3, subfamily A, polypeptide 4
(CYP3A4) inducers (e.g., phenytoin, carbamazepine, phenobarbital, St. John's Wort
[Hypericum perforatum], or rifampin [rifampicin], and/or rifabutin) within 28 days
before randomization

- Subjects with any previously untreated or concurrent cancer that is distinct in
primary site or histology from breast cancer except cervical cancer in-situ, treated
basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that
was curatively treated and without evidence of disease for more than 3 years before
randomization are allowed; all cancer treatments must be completed at least 3 years
prior to study entry (i.e., signature date of the informed consent form)

- History of organ allograft; (including corneal transplant)

- Any malabsorption condition

- Inability to comply with the protocol

- Any condition which, in the investigator's opinion, makes the subject unsuitable for
trial participation