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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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)

Brief 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.

Detailed Summary:

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.


Sponsor: Ohio State University Comprehensive Cancer Center

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival (OS) [ Time Frame: Up to 4 weeks after completion of study treatment ]
    OS will be estimated using the Kaplan-Meier method.
  • Response rate evaluated by RECIST v1.1 [ Time Frame: 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.
  • Incidence of toxicities, graded according to NCI-CTCAE version 4.0 [ Time Frame: Up to 4 weeks after completion of study treatment ]


Original Secondary Outcome: Same as current

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: January 10, 2014
Date Started: April 14, 2014
Date Completion: December 31, 2018
Last Updated: March 1, 2017
Last Verified: March 2017