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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00391248
First Posted: October 23, 2006
Last Update Posted: January 29, 2013
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.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
  Purpose
To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: Erlotinib Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 40
Study Start Date: November 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Erlotinib
    150 mg in a single daily dose, starting Day 1 through Day 22
    Other Name: Tarceva
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00391248


Locations
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
Investigators
Principal Investigator: Jim Wright, MD Juravinski Cancer Centre
  More Information

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00391248     History of Changes
Other Study ID Numbers: CTA-Control-105472
First Submitted: October 19, 2006
First Posted: October 23, 2006
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
tarceva
palliative thoracic radiation therapy

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