Clinical Trials...
Clinical trials are research studies that are designed to test newer treatment regimens. The division of head and neck surgery at University of Tennessee has led or participated in several clinical trials that have resulted in the development of promising new approaches to treat head and neck cancer. To learn more about the clinical trials and why you should participate, click here.
Available Clinical Trials Currently Open For Head & Neck Cancer - As of April, 2009:
Locally Advanced –
OSI3602s: Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy versus Cisplatin and Radiotherapy in Patients with Stage III and IV Squamous Cell Carcinoma of the Head and Neck. (University of Washington) To learn more, click here.
Who is eligible: This trial is suitable for patients with documented Stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. Patients with nasopharyngeal carcinoma can be included if the patients have grades I or II tumors. The patients, also, must have disease that is unresectable or resection is with significant morbidity.
Study Objective: This trial compares the complete response rate in patients with locally advanced head and neck cancer, treated with Cisplatin, radiotherapy and erlotinib versus Cisplatin and radiotherapy alone.
Primary Investigator: Furhan Yunus, M.D.
DeCIDE: A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients with N2/N3 Locally Advanced Head and Neck Cancer. (University of Chicago) To learn more, click here.
Who is eligible: This trial is suitable for patients with N2/N3 squamous cell carcinoma or poorly differentiated carcinomas of an unknown primary originating in the neck. The patient must not have had previous chemotherapy or radiotherapy, and prior surgical therapy must only be organ-sparing procedures.
Study Objective: This trial determines overall patient survival.
Primary Investigator: Sandeep Samant, M.D., F.R.C.S.
Metastatic –
Amgen 20050236: A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects who Fail the Combination Chemotherapy Only Arm. To learn more, click here.
Who is eligible: This trial is suitable for patients with confirmed squamous cell carcinoma or its variants of the head and neck with a primary tumor of the oropharynx, oral cavity, hypopharynx, larynx, or unknown site. Also, patients must have a diagnosis of metastatic disease and/or recurrent disease determined to be incurable by surgery or radiotherapy and must have received no prior systemic treatment for the metastatic and/or recurrent cancer. Patients who have received radiation and/or chemotherapy previously may be eligible.
Study Objective: This trial estimates the effect of Panitumumab on progression free survival (PFS) when added to combination chemotherapy in first-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).
Primary Investigator: Furhan Yunus, M.D.
NCCN FER-HN-015: Cetuximab at either 500 or 750 mg/m2 every other week for Platinum Refractory Cancer of the Head and Neck. To learn more, click here.
Who is eligible: This trial is suitable for patients with squamous cell carcinoma of the head and neck with previous platinum-based chemotherapy for recurrent disease or ineligibility for current or further platinum therapy.
Study Objective: The primary objective of this study is to evaluate the response rate of two separate doses of Cetuximab as monotherapy in platinum refractory patients with cancer of the head and neck.
Primary Investigator: Furhan Yunus, M.D.
Pending Clinical Trials:
IRX Therapeutics: A randomized clinical trial of neoadjuvant immunotherapy in patients with selected, resectable Stage II, Stage III, and Stage IVA cancer of the head and neck. To learn more, click here.
Study Objective: This Phase III trial will investigate the safety and effectiveness of a neoadjuvant peri-lymphatic biologic product in combination with low-dose IV chemotherapy, a NSAID, and zinc in eligible patients.
A Phase II Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer. (Southern Illinois University)
Study Objective: This trial will assess the 2-year overall survival of patients with resectable stage III-IV squamous cell carcinoma of the oropharynx treated with TPF induction chemotherapy followed by conservation (organ preservation) surgery for clinically complete responders.
