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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391248
Recruitment Status : Completed
First Posted : October 23, 2006
Last Update Posted : January 29, 2013
Roche Pharma AG
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)
Study Start Date : November 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Drug: Erlotinib
    150 mg in a single daily dose, starting Day 1 through Day 22
    Other Name: Tarceva

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00391248

Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M5N 3M5
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Roche Pharma AG
Principal Investigator: Jim Wright, MD Juravinski Cancer Centre

Responsible Party: Ontario Clinical Oncology Group (OCOG) Identifier: NCT00391248     History of Changes
Other Study ID Numbers: CTA-Control-105472
First Posted: October 23, 2006    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: April 2011

Keywords provided by Ontario Clinical Oncology Group (OCOG):
non-small cell lung cancer
palliative radiation
palliative thoracic radiation therapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action