Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer
Status:
Completed
Trial end date:
2016-11-09
Target enrollment:
Participant gender:
Summary
The objectives for this study is as follows:
- Primary:
- To evaluate the progression-free survival of locoregionally advanced (stages
III/IV) SCCHN patients undergoing postoperative chemoradiotherapy with panitumumab.
- Secondary:
- To evaluate the overall survival, event-free survival, and toxicities.
- To correlate efficacy parameters with 1) EGFR and downstream pathway activation, 2)
FcyR polymorphisms, and 3) serum cytokine profiles. More specifically, the aim is
to demonstrate the usefulness of biomarkers (downstream signaling molecules, FcyR
polymorphisms, or tumor and serum cytokine(s) in predicting progression-free
survival in patients with SCCHN treated with the above treatment. Specific
biomarkers that relate to Epidermal Growth Factor Receptor and angiogenesis,
including EGFR, pEGFR, Src, pMAPK, pSTAT3, pSTAT5, pSTAT1, pAKT, p38, p21, p27,
PARP, E-cadherin, p-ErbB3, Ki67, VEGF, and IL-8, using reverse phase protein
microarrays (RPPA) will be tested in baseline archival paraffin-embedded tumor
tissue. To collect tumor tissue from pretreatment biopsies for cytokine/chemokine
and immune biomarker studies on tumor tissue. We plan to investigate the expression
of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis
biomarkers. In addition, EGFR polymorphisms will be studied in tumor tissue samples
and serum. Additional studies may be performed in the future. Some of these studies
may be performed by Amgen.