- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02035527
Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase I/II Clinical Trial of Sorafenib in Combination With Cisplatin and Docetaxel in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Overview
Status
Conditions
- Tongue Cancer
- 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 Squamous Cell Carcinoma
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Nasopharynx
- Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
- 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
- Untreated Metastatic Squamous Neck Cancer With Occult Primary
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (sorafenib tosylate, docetaxel, and cisplatin)
Patients receive sorafenib tosylate PO BID on days 1-14 of course 0. Beginning in course 1, patients receive sorafenib tosylate PO BID on days 1-21, docetaxel 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.Correlative studies will be performed and 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.
|
Given daily PO in the a.m.
Other Names:
Given IV over 1 hour following Docetaxel administration
Other Names:
Given IV 1 hour prior to cisplatin administration
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of dose-limiting toxicity (DLT) as graded according to the NCI-CTCAE v4.0 (Phase I)
Time Frame: Day 21 of course 1
|
A DLT will be considered a grade 3 non-hematologic toxicity or grade 4 hematologic toxicity that are probably or definitely related to treatment and result in treatment delay of more than 14 days.
|
Day 21 of course 1
|
Progression-free survival (PFS) (Phase II)
Time Frame: Time of enrollment to the date of progression diagnosis or death, assessed up to 4 weeks after completion of study treatment
|
PFS will be estimated using the Kaplan-Meier method.
|
Time of enrollment to the date of progression diagnosis or death, assessed up to 4 weeks after completion of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Up to 4 weeks after completion of study treatment
|
OS will be estimated using the Kaplan-Meier method.
|
Up to 4 weeks after completion of study treatment
|
Response rate evaluated by RECIST v1.1
Time Frame: Up to 4 weeks after completion of study treatment
|
Up to 4 weeks after completion of study treatment
|
|
Biomarker levels
Time Frame: Up to 42 days
|
Biomarkers from tissue and blood samples will be evaluated and correlated with outcome parameters.
Correlative biomarkers will be analyzed using mixed model for repeated measurement to account for the association of measures overtime from the same patient.
|
Up to 42 days
|
Incidence of toxicities, graded according to NCI-CTCAE version 4.0
Time Frame: Up to 4 weeks after completion of study treatment
|
Up to 4 weeks after completion of study treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthew Old, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Respiratory Tract Neoplasms
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Neoplastic Processes
- Paranasal Sinus Diseases
- Nose Diseases
- Neoplasm Metastasis
- Neoplasms, Squamous Cell
- Nasopharyngeal Neoplasms
- Salivary Gland Diseases
- Mouth Neoplasms
- Tongue Diseases
- Nose Neoplasms
- Head and Neck Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Recurrence
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Neoplasms, Unknown Primary
- Oropharyngeal Neoplasms
- Salivary Gland Neoplasms
- Laryngeal Neoplasms
- Laryngeal Diseases
- Carcinoma, Verrucous
- Tongue Neoplasms
- Paranasal Sinus Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protein Kinase Inhibitors
- Docetaxel
- Sorafenib
Other Study ID Numbers
- OSU-13141
- NCI-2013-02086 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tongue Cancer
-
Indiana UniversityWithdrawnTongue Cancer | Tongue TumorUnited States
-
Fuda Cancer Hospital, GuangzhouShenzhen Hank Bioengineering InstituteCompletedRecurrent Tongue CancerChina
-
Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Seoul National University... and other collaboratorsRecruitingSurgery | Tongue Cancer | Squamous Cell Carcinoma | Resection Margin | Tongue Cancer TNM Staging Primary Tumor (T) T1 | Tongue Cancer TNM Staging Primary Tumor (T) T2Korea, Republic of
-
University of MichiganRecruitingOral Cancer | Tongue Cancer | Tongue NeoplasmsUnited States
-
tiejun ZhangUnknown
-
Oslo University HospitalOslo Metropolitan UniversityCompleted
-
National Taiwan University HospitalNot yet recruiting
-
Centre Hospitalier Universitaire DijonCompleted
-
Tata Memorial HospitalNATIONAL CANCER GRIDRecruitingCancer of the Head and Neck | Cancer of Mouth | Cancer of the Tongue | Buccal Mucosa Cancer | Floor of Mouth CarcinomaIndia
-
Sunnybrook Health Sciences CentreUniversity of Toronto; Sunnybrook Research InstituteRecruiting
Clinical Trials on sorafenib tosylate
-
National Cancer Institute (NCI)CompletedMultiple Endocrine Neoplasia Type 2A | Multiple Endocrine Neoplasia Type 2B | Recurrent Thyroid Gland Medullary Carcinoma | Hereditary Thyroid Gland Medullary Carcinoma | Locally Advanced Thyroid Gland Medullary Carcinoma | Sporadic Thyroid Gland Medullary Carcinoma | Stage III Thyroid Gland Medullary... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingGastrointestinal Stromal TumorUnited States
-
National Cancer Institute (NCI)CompletedPreviously Treated Myelodysplastic Syndrome | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Adult Acute Lymphoblastic Leukemia | Secondary Myelodysplastic Syndrome | de Novo Myelodysplastic Syndrome | Adult Acute Monoblastic Leukemia | Adult Acute Monocytic... and other conditionsUnited States
-
National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedRecurrent Ovarian Carcinoma | Primary Peritoneal CarcinomaUnited States
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
-
Kyowa Hakko Kirin Pharma, Inc.CompletedPeripheral T-Cell LymphomaUnited States
-
Ohio State University Comprehensive Cancer CenterBayerTerminated
-
National Cancer Institute (NCI)CompletedAdvanced Malignant NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedJuvenile Myelomonocytic Leukemia | Recurrent Disease | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid Leukemia | Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Childhood Solid Neoplasm | Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Philadelphia... and other conditionsUnited States, Canada
-
National Cancer Institute (NCI)CompletedHilar Cholangiocarcinoma | Recurrent Gallbladder Carcinoma | Unresectable Extrahepatic Bile Duct Carcinoma | Unresectable Gallbladder Carcinoma | Gallbladder Adenocarcinoma | Recurrent Extrahepatic Bile Duct Carcinoma | Extrahepatic Bile Duct Adenocarcinoma | Gallbladder Adenocarcinoma With Squamous... and other conditionsUnited States