Phase I/II Study of Postoperative Adjuvant Chemoradiation for cSCCHN
I. To determine the MTD (maximally tolerated dose) of OSI-906 (linsitinib) when used in
combination with erlotinib (erlotinib hydrochloride) and radiation therapy after surgery for
advanced-stage cutaneous squamous cell carcinoma of the head and neck (cSCCHN). (Phase I)
II. To estimate the 2-year overall survival (OS) compared to historical controls. (Phase II)
I. To determine the safety and tolerability of OSI-906 in combination with erlotinib and
radiation therapy after surgery for advanced-stage cSCCHN.
II. To estimate the 2-year disease specific and disease free survival. III. To determine the
time to recurrence and patterns of failure. IV. To evaluate the effects of short-term
preoperative treatment with erlotinib and OSI-906 on the expression epidermal growth factor
receptor (EGFR), insulin-like growth factor 1 receptor (IGF-1R) and parallel or downstream
molecular targets in cSCCHN in one third of the patients.
Optional non-therapeutic (biomarker) portion: Patients are randomized to 1 of 3 treatment
Arm A: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) and linsitinib
PO twice daily (BID) on days 1-7 or 1-14.
Arm B: Patients receive erlotinib hydrochloride PO QD and placebo PO QD or BID on days 1-7
Arm C: Patients receive linsitinib PO BID and placebo PO QD or BID on days 1-7 or 1-14.
Treatment continues until 1 day before planned surgical resection (for up to 28 days if
surgery is delayed).
Therapeutic portion: This is a phase I dose-escalation study of linsitinib followed by a
phase II study.
Patients undergo standard QD conventional radiotherapy at the discretion of the treating
physician. Patients receive concurrent linsitinib PO BID and erlotinib hydrochloride PO QD
during the entire course of radiation in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up at 6 and 12 weeks, every 12-16
weeks for 2 years, every 6 months for 3 years, and then annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with overall survival(OS) after two years of treatment (Phase II)
The 2-year OS and 95% confidence interval will be determined using Kaplan-Meier method.
Up to 2 years
OHSU Knight Cancer Institute
United States: Food and Drug Administration
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