At a glance
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Los Tres Paso Trial: Step One - Neoadjuvant Palbociclib Monotherapy, Step Two - Concurrent Chemoradiation Therapy, and Step Three - Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Palbociclib, Cetuximab, and 4 other interventions for Head and Neck Squamous Cell Carcinoma. Active but no longer recruiting, targeting 26 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or cetuximab + IMRT depending on patient characteristics), followed by adjuvant single-agent palbociclib.
Study Details
Timeline
Interventions
Palbociclib is an oral drug available as capsules (or as liquid suspension). The capsules should be taken with food
-Cetuximab must not be administered as an IV push or bolus
-Patients will receive cisplatin via intravenous (IV) infusion over 60 minutes.
-Once daily fractions Monday through Friday, with one additional fraction of RT administered on (preferably) Fridays
* Tumor tissue will be collected at baseline and then after two cycles of neoadjuvant palbociclib monotherapy * If the patient has been previously enrolled in Washington University's TAP protocol (head and neck bank, HRPO #201102323), tissue that has been banked may be accessed in lieu of fresh biopsy at baseline.
Baseline and post-treatment