Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)

January 28, 2013 updated by: Ontario Clinical Oncology Group (OCOG)

A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)

To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M5N 3M5
        • Toronto Sunnybrook Regional Cancer Centre

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:

  • Histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and
  • Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and
  • At least 18 years of age.

Exclusion Criteria:

  • Previous erlotinib therapy; or
  • Planned concurrent chemotherapy; or
  • Expected survival of less than 3 months; or
  • ECOG Performance Status of 3 or 4; or
  • Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or
  • Granulocyte count <1,500/mm3, platelet count <100,000/mm3, or haemoglobin <9.0g/dl; or
  • SGOT (AST) or SGPT (ALT) > 2.5 times (x) upper limit of normal (ULN) in the absence of known liver metastases or > 5 x ULN in case of known liver metastases; or
  • Alkaline phosphatase (ALP) > 2.5 x ULN; or
  • Serum bilirubin > 1.5 ULN; or
  • Serum creatinine > 1.5 ULN or creatinine clearance < 60 ml/min; or
  • Serum calcium beyond ULN; or
  • Patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see Appendix VI for complete list of medications); or
  • A history of interstitial lung disease; or
  • Known sensitivity to erlotinib; or
  • Pregnancy, lactation, or parturition within the previous 30 days; or
  • Unwillingness or inability to complete the required assessments of the trial; or
  • Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or
  • History of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye.
  • Geographically inaccessible for treatment or follow-up evaluations; or
  • Involved in an ongoing therapeutic trial.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy
Time Frame: 4 weeks post radiotherapy
4 weeks post radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
The improvement in global quality of life and total scores of the LCSS at four weeks following treatment, radiological response, and the incidence and severity of adverse events as per the CTCAE version 3
Time Frame: 4 weeks post radiotherapy
4 weeks post radiotherapy

Collaborators and Investigators

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

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Jim Wright, MD, Juravinski Cancer Centre

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

November 1, 2006

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 23, 2006

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTA-Control-105472

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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