Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer
- Determine feeding tube dependency at 12 months in patients with locally advanced head
and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin,
and fluorouracil followed by cisplatin and reduced-dose radiotherapy.
- Determine the progression-free, disease-free, and overall survival of patients treated
with this regimen.
- Determine the pattern of failure in patients treated with this regimen.
- Evaluate the quality of life of patients treated with this regimen.
- Assess pre- and post-treatment swallowing ability of patients and the impact on their
quality of life.
- Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for
head and neck malignancy.
- Evaluate the quality of saliva by examining total protein concentrations.
- Quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8, and vascular
endothelial growth factor) in the saliva of these patients.
- Determine the degree of mucositis and xerostomia of patients receiving chemotherapy
with radiotherapy for head and neck malignancy.
- Compare salivary flow rates with the grade of mucositis and xerostomia of patients
receiving chemotherapy with radiotherapy for head and neck malignancy.
OUTLINE: This is a pilot study.
- Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1
hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also
receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day
5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression
or unacceptable toxicity. Patients achieving a partial or clinical complete response
proceed to chemoradiotherapy 3 weeks later.
- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment
repeats every 3 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5
days a week for 6 weeks.
- Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with
residual neck disease or disease initially staged at N2 or greater undergo neck
Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic
cytokines (interleukin [IL]-1, IL-6, IL-8 and vascular endothelial growth factor); and
examine the grade of mucositis and xerostomia.
Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last
radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.
After completion of study treatment, patients are followed periodically for 5 years and then
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Feeding Tube Dependency
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
at 12 months
Frank G. Ondrey, MD, PhD
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|