Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Recurrent Skin Cancer
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Skin Neoplasms
  • 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

NCT number NCT01465815
Study type Interventional
Source OHSU Knight Cancer Institute
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date December 2011
Completion date September 2013

See also
  Status Clinical Trial Phase
Completed NCT01155609 - L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer N/A
Completed NCT01044433 - Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck Phase 2
Completed NCT00407810 - Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00096512 - S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00098631 - Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer Phase 2
Completed NCT00055770 - Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer Phase 1/Phase 2
Completed NCT00470496 - Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer Phase 1
Terminated NCT01249443 - Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Phase 1
Completed NCT01637194 - Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer Phase 1
Completed NCT00033618 - Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck Phase 2
Completed NCT01816984 - PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT01674374 - Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy Phase 2
Terminated NCT01528137 - Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer Phase 1
Active, not recruiting NCT01847326 - Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer Phase 1
Completed NCT00114283 - Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Phase 2
Completed NCT00055913 - Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 1/Phase 2
Completed NCT01334177 - TLR8 Agonist VTX-2337 and Cetuximab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Squamous Cell Cancer of Head and Neck Phase 1
Completed NCT00492089 - Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer Phase 2
Completed NCT00939627 - Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab Phase 2
Terminated NCT00906360 - Sunitinib, Cetuximab, and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 1