Clinical Research Details

A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent Or Metastatic Head and Neck Cancer

The purpose of this study is: • To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard cisplatin-based chemotherapy with or without bevacizumab. • To assess toxicities with the addition of bevacizumab to each cisplatin-doublet (cisplatin/docetaxel and cisplatin/5-FU). • To compare the objective response rates and the progression-free survival achieved with the above therapies. • To collect blood samples before and after therapy for future correlative studies. • To collect tumor tissue samples available at baseline from prior diagnostic procedures for future correlative studies.

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• Patients must have histologically or cytologically confirmed squamous cell cancer of the head and neck (SCCHN) from any primary site. Patient must not have nasopharyngeal carcinoma of histologic types WHO 2 or 3 or squamous cell carcinoma that originated in the skin.
• Patients must have SCCHN that is either (a) recurrent, judged incurable by surgery or radiation or (b) metastatic.
• NOTE: Patients who refuse radical resection for recurrent disease are eligible.
• No prior chemotherapy or biologic/molecular targeted therapy for recurrent or metastatic SCCHN.
• Patients may have received one regimen of induction, concomitant chemoradiotherapy and/or adjuvant chemotherapy as part of initial potential curative therapy but must not have received prior chemotherapy for recurrent or metastatic disease.
• A minimum of six months is required between last dose of chemotherapy or chemoradiotherapy and study treatment. In addition, patients must be progression-free for at least six months after completion of chemotherapy, chemoradiotherapy or radiation plus cetuximab given with a curative intent. (Cetuximab therapy: Six months is required between last dose of chemotherapy or chemoradiotherapy and study treatment if part of concurrent regimen, eight weeks if part of adjuvant regimen post radiation.)
• Patients having progression after two cycles of induction chemotherapy are not eligible for the study.
• No prior bevacizumab is allowed.
• A maximum of one prior radiotherapy regimen, curative or palliative, to the head and neck is allowed. If the radiation is combined with chemotherapy and/or cetuximab, a period of six months must elapse between the end of radiotherapy and study treatment. If the radiation is given alone, a minimum of eight weeks must elapse between the end of radiotherapy and registration. A minimum of three weeks must elapse between prior radiation to other areas and registration.
• Patients must not be receiving any other investigational agent while on the study.

You will be randomized into one of the study groups described below. Randomization means that you are put into a treatment group by chance. It is like flipping a coin. Which group you are put in is done by a computer. Neither you nor the researcher will choose which group you will be in. You will have an equal chance of being placed in either group. You will be in Group A or Group B.

The treatment of your disease does not routinely require hospitalization. However, 5-FU continuous infusion may be given in the hospital over four days.

If you take part in this research study and are in Group A, on day 1:

• You will receive cisplatin plus docetaxel or cisplatin plus 5-FU.

If you take part in this research study and are in Group B, on day 1:

• You will receive docetaxel plus cisplatin plus bevacizumab or cisplatin plus bevacizumab plus 5-FU.

Cheryl Czerlanis, M.D.

(708) 327-3229