This randomized phase II trial studies how well cisplatin or carboplatin and docetaxel with or without erlotinib hydrochloride works in treating patients with stage III-IVB mouth (oral cavity) cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin, carboplatin, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without erlotinib hydrochloride in treating oral cavity cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01927744.
PRIMARY OBJECTIVES:
I. To assess major pathologic response among patients with locally advanced oral cavity squamous cell carcinomas treated with induction cisplatin/carboplatin, docetaxel and erlotinib (erlotinib hydrochloride) prior to surgery, and to compare it with the major pathologic response among patients treated with cisplatin/carboplatin, docetaxel, and placebo, in the trial population overall and in biomarker-defined subgroups.
SECONDARY OBJECTIVES:
I. To assess safety and toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. To assess overall survival.
III. To assess recurrence-free survival.
IV. To assess progression-free survival.
V. To assess response rate and disease control rate, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
VI. To assess percentage of viable tumor cells in surgical specimen.
VII. To correlate tissue and blood-based biomarkers with outcome and toxicity.
VIII. To assess quality of life, determined by the self-reported Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive docetaxel intravenously (IV) and carboplatin or cisplatin IV over 1-2 hours on day 1. Patients also receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21.
ARM II: Patients receive docetaxel and carboplatin or cisplatin as in Arm I. Patients also receive placebo PO QD on days 1-21.
In both arms, treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard surgical resection.
After completion of study treatment, patients are followed up at 8 weeks and then annually thereafter.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorXiuning Le
