Cancer

Title
Chemotherapy in Patients With Recurrent Head and Neck Cancer
Trial Number
202236102109
Number of Participants
400
Principal Investigator

Cheryl Czerlanis

M.D.
Hematology/Oncology
Assistant Professor
Eligibility

• 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.

Purpose

The purpose of this study is to compare the effects (good and bad) of the addition of bevacizumab to standard chemotherapy (cisplatin and docetaxel or cisplatin and 5-FU) and to determine if the combination of standard chemotherapy and bevacizumab can increase the effectiveness of treatment for head and neck cancer. This combination is experimental.

Enrollment

(708) 327-3229

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