Phase II Study of DCA (Dichloroacetate) in Combination With Cisplatin and Definitive Radiation in Stage III-IV Squamous Cell Carcinoma of the Head and Neck
Doses for Cisplatin will be based on actual body weight taken on each day of Cisplatin
therapy. DCA doses will be calculated at baseline according to actual body weight and will
not change during the 8 weeks of therapy.
A careful description of the extent of the primary lesion and nodal spread will be recorded.
Dental Evaluation: Prior to treatment, patients will be evaluated by the dental service and
a prophylactic cleaning/fluoride regimen instituted. A delay of at least 14 days from major
surgery, including dental extractions, will be required prior to Day 1 treatment.
Airway Patency: Significant laryngeal edema has been described after the use of cisplatin
containing regimens. Patients with laryngeal tumors should be considered for a prophylactic
tracheostomy prior to the initiation of chemotherapy, if any possibility of airway
compromise exists. Patients with laryngeal tumors experiencing respiratory stridor or
compromise shortly after chemotherapy/radiotherapy administration should be rapidly
evaluated for tracheostomy.
Alimentation: Significant stomatitis, mucositis and dysphagia are expected with these
treatment regimens. Hospitalization may be required for symptomatic management. Pronounced
weight loss is common, and adequate alimentation needs to be maintained. Early, if not
pre-emptive, enteral tube feedings should be considered if difficulty is anticipated.
Compliance: The complexity of these treatment regimes and their attendant toxicity are such
that compliance is of major concern. Patients expected to pose compliance problems should
not be entered on this study. Patients will need to be seen at least weekly during therapy
so that the toxicities can be monitored and treated.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
To evaluate the safety of delivering DCA during primary chemo-radiation.
The safety objectives that will be monitored will include but are not limited to mucositis, leucopenia, neuropathy, and treatment breaks. This will be done according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
A safety evaluation will be conducted after the first six patients are enrolled into the safety cohort, at approximately 7 months from study opening.
John H Lee, MD
United States: Food and Drug Administration
|Sanford Roger Maris Cancer Center||Fargo, North Dakota|
|Sanford Hematology and Oncology||Sioux Falls, South Dakota 57104|