Nab-Paclitaxel-based Re-induction Chemotherapy Followed by Response-stratified Chemoradiotherapy in Patients With Previously Treated Squamous Cell Carcinoma of the Head and Neck.
I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of
nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) when given in
combination with FHX (5 fluorouracil [fluorouracil], hydroxyurea and twice daily radiation,
in good induction responders) and of nab-paclitaxel added to hypofractionated radiotherapy
for poor responders.
II. To explore the feasibility of a more rapid palliative chemoradiotherapy approach
inpatients with refractory disease as demonstrated by failure to respond to initial
III. To explore the role of induction chemotherapy as a predictive tool for definitive head
and neck cancer management of previously treated patients.
I. Progression-free survival (PFS) (time to disease progression or death from any cause) on
both study arms.
II. Overall survival and response rates in both arms.
I. To determine the correlation of secreted protein, acidic, cysteine-rich (SPARC)
expression in head and neck cancer and response to therapy.
OUTLINE: This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle
RE-INDUCTION THERAPY (WEEKS 1-6): Patients receive paclitaxel albumin-stabilized
nanoparticle formulation intravenously (IV) over 30 minutes on days 1 and 8 and carboplatin
IV over 30 minutes on day 1. Courses repeat every 21 days for 2 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving good response undergo
surgical resection and proceed to chemoradiation within 4-6 weeks.
AFHX REGIMEN: Patients achieving response to re-induction therapy receive hydroxyurea orally
(PO) every 12 hours for 6 days (11 doses) beginning on day 0, fluorouracil IV continuously
over 120 hours beginning on day 0, and paclitaxel albumin-stabilized nanoparticle
formulation IV over 30 minutes on day 1. Patients also undergo radiation therapy twice daily
(BID) on days 1-5. Courses repeat every 14 days for 5 weeks in the absence of disease
progression or unacceptable toxicity.
PACLITAXEL + RADIATION (AXX) REGIMEN: Patients not achieving response to re-induction
therapy receive paclitaxel albumin-stabilized nanoparticle formulation IV and undergo
hypofractionated radiation therapy on day 1. Courses repeat every 7 days for 5 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 3 months, every 3
months for 2 years, every 6 months for 2 years, and then yearly thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with fluorouracil, hydroxyurea, and radiation therapy, determined according to incidence of DLT graded using the National Cancer Institute (NCI) CTCAE 4.0
University of Chicago Comprehensive Cancer Center
United States: Institutional Review Board
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