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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT01465815
Phase
PHASE1/PHASE2
Status
Withdrawn

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Nov 7, 2011
Start date
Dec 31, 2011
Status verified
Nov 2014
Primary completion
Sep 30, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (adjuvant enzyme inhibitor and radiation therapy)
    Optional non-therapeutic (biomarker) portion: Patients are randomized to 1 of 3 treatment arms. Arm A: Patients receive erlotinib hydrochloride PO QD and linsitinib PO 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.
  • Experimental: Erlotinib and Placebo (Sugar Pill)
    Arm B: Patients receive erlotinib hydrochloride PO QD 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.
  • Experimental: OSI-906 and Placebo (Sugar Pill)
    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.

Primary Outcome Measure

Number of participants with overall survival(OS) after two years of treatment (Phase II) [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

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By research site
OHSU Knight Cancer Institute· Portland, OR

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