Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
Phase I Study Panitumumab Plus Chemoradiotherapy and Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck
This study is being done to test whether panitumumab, in combination with chemotherapy and radiation is safe in people with head and neck cancer. Another goal of this study is to find the highest dose of the study drugs that can be given safely without causing serious sife effects. Panitumumab is a type of drug called a monoclonal antibody that has been studied in other types of cancers, such as kidney and colon. This monoclonal antibody is directed against the epidermal growth factor receptor (EGFR). EGFR has been found on the majority of head and neck cancer cells. By blocking EGFR, this monoclonal antibody may inhibit the growth of head and neck cancer cells.
- There are two parts to this study: Part A and Part B. Participants enrolled in Part A
of this study received panitumumab and chemoradiotherapy. Participants enrolled in Part
B will receive panitumumab in combination with induction chemotherapy followed by
chemoradiotherapy.
- The main purpose of Part A was to examine the safety and the best dosing of
panitumumab, chemotherapy and radiation for the treatment of head and neck cancer. The
best dosing was determined by increasing doses of chemotherapy given in combination
with panitumumab during radiation. The chemotherapy drugs being used in Part A were
carboplatin and paclitaxel, which are standard therapies used in head and neck cancer.
These drugs were be added to radiation and this combination is called
chemoradiotherapy. The investigators have determined the best dose of panitumumab and
chemotherapy to give with radiation, Part B has now begun.
- The main purpose of Part B is to examine the safety and best dosing of chemotherapy
combined with panitumumab (called induction therapy) prior to receiving panitumumab and
chemoradiotherapy. The drugs that are used for induction chemotherapy will be
docetaxel, cisplatin and 5-fluorouracil. These drugs are also standard therapies used
in head and neck cancer.
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