Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases.
  • Scheduled to receive cisplatin chemotherapy of 80-100 mg/m².
  • Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 Gy at each site.

• Key Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Current mucositis.
  • Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial.
  • Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT.
  • Prior radiation to the head and neck.
  • Chemotherapy treatment within the previous 12 months.
  • Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx.
  • Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance <30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per μL.
  • Evidence of immediate life-threatening disease or a life expectancy of less than 3 months.
  • Women who are pregnant or breastfeeding.
  • Participation in any study involving administration of an investigational agent within 30 days of randomization into this study.