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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Tertiary
- 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
dissection.
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
annually thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Interventional
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
No
Frank G. Ondrey, MD, PhD
Principal Investigator
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
2005LS012
NCT00352118
March 2006
April 2008
Name | Location |
---|---|
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |