Phase I Trial of ABI-007 (Abraxane) Plus Cisplatin Plus 5-Fluorouracil (APF) as Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Squamous Cell Cancers of the Head and Neck (HNSCC)
Squamous cell carcinoma of the head and neck (HNSCC) is the 9th most common malignancy
diagnosed in Canadians. In the year 2007, there was an estimated 4,350 new cases diagnosed
in Canada, with approximately 1,600 deaths attributable to HNSCC[Canadian Cancer Statistics
2007]. In the United States there is an annual incidence of approximately 40,000 newly
diagnosed cases of head and neck cancer [US Cancer Statistics 2006]. Primary treatment for
newly diagnosed localized (stage I-II) HNSCC is surgery and/or radiotherapy. The majority of
patients (70%) however present with locally advanced HNSCC (Stage III or IV). Treatment of
locally advanced HNSCC generally consists of either concurrent chemotherapy and radiation or
surgical resection followed by adjuvant radiation or adjuvant concurrent chemotherapy and
radiation. Unfortunately despite aggressive treatment with combined modality therapies
approximately 40-50% of cases recur, with the majority recurring at the primary site and/or
regional nodes. Except for a small minority of patients in whom salvage surgery or
radiotherapy can be delivered, the prognosis for the majority of these patients is poor and
further treatment is generally considered palliative.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The maximum tolerated dose of ABI-007 with Cisplatin and 5-Fluorouracil (APF)
two years
Yes
Lillian Siu, MD
Principal Investigator
University Health Network - Princess Margaret Hospital
Canada: Health Canada
APF-001
NCT00731380
July 2008
March 2013
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