Squamous Cell Carcinoma Of The Head And Neck Clinical Trial
Official title:
Phase II Trial of Cetuximab and Dasatinib in Patients With Cetuximab-resistant, Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck and Low Serum IL-6
This is a single-arm, non-masked, open-label, Phase II study of cetuximab + dasatinib in
recurrent Squamous Cell Carcinoma of The Head and Neck (SCCHN) that has recurred after
cetuximab-containing therapy (please see attached schema).
The primary endpoint 12-week PFS.
Patients must have recurrent SCCHN and may have received any number of prior palliative
systemic therapies for recurrent disease (without cetuximab or othr EGFR inhibitor). One
prior curative regimen (induction, primary or postoperative chemoradiotherapy) should have
been given AND all patients should have been exposed to cetuximab as part of prior
potentially curative treatment.Those who have received a prior Src kinase inhibitor or EGFR
inhibitor other than cetuximab are not eligible.
Patients will be tested for serum IL-6. If IL-6 is detectable, the patient will be
ineligible. If IL-6 is not detected, the patient will be eligible for the study. Subjects
more than 2 weeks post last dose of Cetuximab will receive an initial loading dose 400 mg/m2
on cycle 1, day 1. Subjects who have received Cetuximab within 2 weeks of starting study will
start Cycle 1 with dose of 250 mg/m2. Dasatinib will start 3 days after initial cetuximab
study dose on cycle 1 (i.e cycle 1, day 4), and continue without interruption.
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