Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer

May 8, 2013 updated by: Renato Martins, University of Washington

Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck

This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Compare the complete response rate in patients with locally advanced head and neck cancer, treated with cisplatin, radiotherapy and erlotinib (erlotinib hydrochloride) versus cisplatin and radiotherapy alone.

SECONDARY OBJECTIVES:

I. Evaluate whether the addition of erlotinib increases the acute and long term toxicities of cisplatin and radiotherapy, in patients with locally advanced head and neck cancer.

II. Compare the disease-free and overall survivals of patients with locally advanced head and neck cancer treated with cisplatin and radiotherapy, with and without erlotinib.

III. Evaluate whether the symptomatic improvement observed in the first week of erlotinib alone predicts for complete response and long term disease control.

IV. Correlate epidermal growth factor receptor (EGFR), p16 and excision repair cross-complementing 1 (ERCC-1) expression with response outcome to therapy with cisplatin and radiation with and without erlotinib.

V. Identify other molecular correlates that may be relevant in the pathogenesis of squamous cell carcinoma of head and neck (SCCHN) or response to therapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride orally (PO) once daily (QD) on days -7 to 47.

ARM II: Patients receive cisplatin and undergo radiotherapy as in Arm I.

Within 10-14 weeks after completion of study treatment, patients with N2 or N3 disease at the time of screening undergo a neck dissection.

After completion of study treatment, patients are followed up periodically for 5 years.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

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

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology LLC
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Science CCOP
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Wilmington, North Carolina, United States, 28401
        • New Hanover Radiation Oncology Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Cancer Institute-Boston Cancer Group PLC
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
      • Tacoma, Washington, United States, 98415
        • MultiCare Health System

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cytological or pathological documented squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx; patients with nasopharyngeal carcinoma can be included if the patients have grades I or II tumors according to the World Health Organization (WHO) classification
  • Stage III or IV according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Sixth Edition (2002)
  • Unresectable or resection with significant morbidity
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Measurable Disease, defined according to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
  • Bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
  • Calculated creatinine clearance >= 55ml/min (using the Cockcroft-Gault formula)
  • Platelet count >= 100 x 10^9 /L
  • Absolute neutrophil count (ANC) >= 1.25 x 10^9 /L
  • Signed informed consent
  • Male and female patients with reproductive potential must use an acceptable contraceptive method
  • Authorization from a dentist to begin radiation therapy

Exclusion Criteria:

  • Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
  • Inability or unwillingness to comply with radiotherapy
  • Evidence of clinically significant congestive heart failure; patients must be able to tolerate hydration required during cisplatin chemotherapy
  • Diarrhea > grade 1 at the time of enrollment
  • Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck
  • Prior treatment with an investigational or marketed inhibitor of the EGFR pathway
  • Use of cytochrome P450 3A4 (CYP3A4) inducers
  • Presence of systemic metastases (M1)
  • Pregnant or breast-feeding women
  • Known human immunodeficiency virus (HIV) infection

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride PO once daily on days -7 to 47.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Drug: cisplatin
Given IV
Other Names:
  • CDDP
  • DDP
  • CACP
  • CPDD
Drug: erlotinib hydrochloride
Given orally
Other Names:
  • OSI-774
  • erlotinib
  • CP-358,774
Radiation: 3-dimensional conformal radiation therapy
35 fractions
Other Names:
  • 3D-CRT
  • conformal radiation therapy
Radiation: intensity-modulated radiation therapy
35 fractions
Other Names:
  • IMRT
Active Comparator: Arm II (chemotherapy, radiotherapy)
Patients receive cisplatin and radiotherapy as in Arm I.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Drug: cisplatin
Given IV
Other Names:
  • CDDP
  • DDP
  • CACP
  • CPDD
Radiation: 3-dimensional conformal radiation therapy
35 fractions
Other Names:
  • 3D-CRT
  • conformal radiation therapy
Radiation: intensity-modulated radiation therapy
35 fractions
Other Names:
  • IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
Time Frame: 12 weeks after the completion of therapy
Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
12 weeks after the completion of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm
Time Frame: 30 days after the completion of therapy
30 days after the completion of therapy
Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride
Time Frame: Every 3 months for up to 5 years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Every 3 months for up to 5 years

Collaborators and Investigators

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

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2006

Primary Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 11, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 13, 2006

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6106
  • NCI-2009-01546 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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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