A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer
||Bruce Culliney, MD
| Time frame of study:
|Location of Study:
Mount Sinai Beth Israel
St.Luke's-Mount Sinai Roosevelt
Continuum Cancer Research Program
The systemic therapy (treatment of the whole body system) of recurrent/ metastatic head and neck cancer has produced disappointing results. Bevacizumab is a new drug that targets VEGF (a human endothelial growth factor) and has produced promising results in multiple solid tumors. Bevacizumab is currently FDA approved for advanced colorectal cancer and awaits approval in non-small cell lung cancer. We hypothesize that the addition of bevacizumab to standard cisplatin-based chemotherapy will result in survival benefit in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Therefore, we propose a phase III randomized comparison of cisplatin/docetaxel (or cisplatin/5-FU) with or without bevacizumab.
- Age 18 and older
- Patients must have histologically or cytologically confirmed Squamous Cell Cancer of the Head &Neck (SCCHN), from any primary site. Patient must not have cancer of the nasopharynx of histologic types WHO 2 or 3, or squamous cell carcinoma that originated in the skin.
- No prior chemotherapy or biologic/molecular targeted therapy for recurrent or metastatic SCCHN or any other investigational drug
- 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.
- No prior bevacizumab is allowed.
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