The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as “C225” and “Erbitux”) can increase the effectiveness of standard treatment with chemotherapy and radiation.

Condition	Intervention	Phase
Cancer	Drug: Docetaxel  Drug: Cisplatin  Drug: Carboplatin  Procedure: Radiation Therapy	Phase II

Further Study Details: 

Primary Outcomes: To evaluate the objective response rate with induction with cisplatin/docetaxel/cetuximab in subjects.
Secondary Outcomes: To evaluate the toxicities, objective response rate post chemoradiotherapy, time to progression, overall survival, local and distant failure rates.
Expected Total Enrollment:  40

This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy.

The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Stage III-IVB head and neck cancer, all sites, including unknown primary tumors (bulky stage II (T2N0) lesions of the base of tongue or hypopharynx and patients with stage II nasopharyngeal cancer are also eligible) Prior to study entry the resectability and alternative treatment options will be determined by a team composed of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Unequivocal demonstration of distant metastasis (M1) confers ineligibility
2. Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or WHO types I-III of the nasopharynx
3. Unidimensionally measurable disease is required (RECIST)
4. No prior chemotherapy, biologic/molecular targeted therapy (including any prior therapy which specifically and directly targets the EGFR pathway), or radiotherapy for head and neck cancer
5. Prior surgical therapy will consist only of incisional or excisional biopsy and organ sparing procedures such as debulking of airway compromising tumors or neck dissection in a patient with an existing primary tumor (Any non-biopsy procedure must have taken place > 4 weeks but < 3 months of initiating protocol treatment)
6. ECOG PS 0 or 1; 7. Organ & marrow function per protocol criteria and 8. Age of >=18 years

Exclusion Criteria:

1. History of severe allergic reactions attributed to docetaxel or compounds of similar chemical or biologic composition to docetaxel, or other drugs formulated with polysorbate 80
2. Uncontrolled intercurrent illness or significant history of uncontrolled cardiac disease
3. Receiving any other investigational agents
4. No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, or malignancy that has been treated with a curative intent with a 5-year disease-free survival
5. Significant baseline sensory or motor neurologic deficits (> grade I neuropathy); 6. HIV-positive patients and 7. Prior severe infusion reaction to a monoclonal antibody.

Please refer to this study by ClinicalTrials.gov identifier  NCT00226239

Anthanassios E Argiris, MD      (412) 623-4083    argirisae@upmc.edu

Pennsylvania
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15232,  United States

Study chairs or principal investigators

Athanassios E Argiris, MD,  Principal Investigator,  University of Pittsburgh Cancer Institute   

Study ID Numbers:  05-003
Last Updated:  September 23, 2005
Record first received:  September 22, 2005
ClinicalTrials.gov Identifier:  NCT00226239
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27