Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

August 3, 2023 updated by: NCIC Clinical Trials Group

A Phase I Study of Adjuvant OSI-774 (Tarceva®) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant erlotinib when given after completing chemoradiotherapy in treating patients with locally advanced squamous cell carcinoma (cancer) of the head and neck.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the recommended dose of adjuvant erlotinib after the completion of chemoradiotherapy in patients with stage III, IVA, or IVB squamous cell carcinoma of the head and neck.
  • Determine the toxicity of this drug in these patients.
  • Determine the effects of this drug on plasma and urinary angiogenic factors (specifically vascular endothelial growth factor receptor [VEGFR], VEGFR1, VEGFR2, and basic fibroblast growth factor levels) in these patients.
  • Compare the disease-free survival of patients treated with this drug after chemoradiotherapy vs historical control patients treated with chemoradiotherapy alone.
  • Correlate levels of angiogenic factors with initial blood vessel concentration in the tumor and the presence or absence of EGFRvIII mutation in patients treated with this drug.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 8 patients are treated at that dose level.

Patients are followed at 4 weeks, every 12 weeks for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • London, Canada, N6A 4L6
        • London Regional Cancer Program
      • Montreal, Canada, H2L 4M1
        • CHUM - Hopital Notre-Dame

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck

    • Stage III, IVA, or IVB

  • Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks

    • Prior radiotherapy must have been given with a radical intent with receipt of at least 90% of planned dose

  • No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following:

    • Complete response at primary tumor site and nodes (with or without nodal surgery after chemoradiotherapy)
    • Negative lymph node status (by physical or radiological exam) AND persistent tumefaction less than 25% of original tumor size or residual mass due to scarring
  • Tumor tissue samples available for EGFRvIII mutation analysis
  • No known brain metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • ALT/AST < 2 times upper limit of normal (ULN)
  • Bilirubin < ULN (unless due to Gilbert's syndrome)

Renal

  • Creatinine < 1.5 times ULN

Cardiovascular

  • No myocardial infarction within the past year
  • No cardiac ventricular arrhythmias requiring medication
  • No history of cardiac disease
  • No uncontrolled high blood pressure
  • No unstable angina
  • No congestive heart failure

Ophthalmic

  • No history of severe dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis sicca
  • No severe exposure keratopathy
  • No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
  • No disorder that might increase the risk for epithelium-related complication (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
  • No congenital abnormality (e.g., Fuch's dystrophy)
  • No ocular inflammation or infection

Gastrointestinal

  • Able to take oral medication
  • No gastrointestinal (GI) tract disease requiring IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • No active peptic ulcer disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious active infection
  • No other serious underlying medical condition that would preclude study participation
  • No prior allergic reaction to compounds of similar chemical or biological composition to erlotinib
  • No other malignancy with the past 5 years except adequately treated non-melanoma skin cancer (unless in the same area treated with radical radiotherapy) or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • See Disease Characteristics
  • No prior surgical procedure affecting absorption
  • No concurrent ophthalmic surgery

Other

  • More than 4 weeks since other prior investigational drugs
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance with respect to INR
  • Concurrent nasogastric or gastrostomy tube feeding for dysphagia allowed provided there is no evidence of significant residual mucositis (i.e., > grade 1)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity/feasibility assessed by NCI CTC v2.0 at the end of course 1
Recommended phase II dose at the end of course 1

Secondary Outcome Measures

Outcome Measure
Disease-free survival
Correlative studies (archival and prospective) at accrual completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Collaborators

Roche Pharma AG

Investigators

  • Study Chair: Denis Soulieres, MD, MSC, CHUM - Hotel Dieu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2004

Primary Completion (Actual)

December 9, 2008

Study Completion (Actual)

January 18, 2011

Study Registration Dates

First Submitted

March 8, 2004

First Submitted That Met QC Criteria

March 8, 2004

First Posted (Estimated)

March 9, 2004

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN5
  • CAN-NCIC-HN5 (Other Identifier: PDQ)
  • ROCHE-CAN-NCIC-HN5 (Other Identifier: Roche)
  • CDR0000353485 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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