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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02086 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (sorafenib tosylate, docetaxel, and cisplatin) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sorafenib tosylate | Drug | Given daily PO in the a.m. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) as graded according to the NCI-CTCAE v4.0 (Phase I) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 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 | Up to 4 weeks after completion of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Old, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| cisplatin | Drug | Given IV over 1 hour following Docetaxel administration |
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| docetaxel | Drug | Given IV 1 hour prior to cisplatin administration |
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| Correlative Studies | Other | 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. |
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| Biomarker levels | 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 | Up to 4 weeks after completion of study treatment |
| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D014062 | Tongue Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014060 | Tongue Diseases |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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