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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00391248
First received: October 19, 2006
Last updated: January 28, 2013
Last verified: April 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00391248     History of Changes
Other Study ID Numbers: CTA-Control-105472
Study First Received: October 19, 2006
Last Updated: January 28, 2013
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on April 23, 2014