A Phase I Trial of Abraxane, Cisplatin and 5-Fluorouracil Along With Chemoradiotherapy in Advanced Head and Neck Cancer
The purpose of this study is to determine the highest dose of a ABI-007 that can be given with cisplatin and 5-fluorouracil without causing intolerable side effects in patients with advanced head and neck cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- The maximum tolerated dose of ABI-007 with Cisplatin and 5-Fluorouracil (APF) [ Time Frame: two years ] [ Designated as safety issue: Yes ]
- safety and tolerability profiles for ABI-007 [ Time Frame: two years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: ABI-007 escalation; then radiation + AUC
Dose escalation beginning with ABI-007 75 mg/m2 day 1 + day 8, Cisplatin 100 mg/m2 day 1, 5-FU 1000 mg/m2/d continuous infusion x 96 hours on day 1-4, for 3 weeks x 3 cycles. Followed by Concurrent weekly Carboplatin (AUC 1.5) with radiotherapy for 7 weeks. Carboplatin should be given on Monday or Tuesday of each week, if possible.
Dose escalation beginning with ABI-007 75 mg/m2 day 1 + day 8, Cisplatin 100 mg/m2 day 1, 5-Fluorouracil (5-FU) 1000 mg/m2/d continuous infusion x 96 hours on day 1-4, for 3 weeks x 3 cycles. Followed by Concurrent weekly Carboplatin (AUC 1.5) with radiotherapy for 7 weeks. Carboplatin should be given on Monday or Tuesday of each week, if possible.
Other Name: Abraxane
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731380
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 3M9|
|Principal Investigator:||Lillian Siu, MD||University Health Network - Princess Margaret Hospital|