NCT01465815

Phase I/II Study of Postoperative Adjuvant Chemoradiation for Advanced-Stage Cutaneous Squamous Cell Carcinoma of the Head and Neck (cSCCHN)

Phase I/II Study of Postoperative Adjuvant Chemoradiation for cSCCHN

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of linsitinib when given together with erlotinib hydrochloride and radiation therapy after surgery in treating patients with advanced or recurrent head and neck cancer. Erlotinib hydrochloride and linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy together with erlotinib hydrochloride and linsitinib may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Detailed description

PRIMARY OBJECTIVES: 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) SECONDARY OBJECTIVES: 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. OUTLINE: Optional non-therapeutic (biomarker) portion: Patients are randomized to 1 of 3 treatment arms. 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 or 1-14. 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 toxicity. 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.

Conditions

• Recurrent Skin Cancer
• Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
• Squamous Cell Carcinoma of the Skin
• Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given PO
DRUG	linsitinib	Given PO
DRUG	placebo	Given PO
RADIATION	radiation therapy	Undergo radiation therapy
PROCEDURE	therapeutic conventional surgery	Undergo planned surgery
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-11-07
• Last updated: 2014-11-19

Locations

1 site across 1 country: United States